Stockwinners Market Radar for October 07, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:28 EDT Takeda Pharmaceutical: FDA recommends maribavir for post-transplant CMV - Takeda Pharmaceutical announced the U.S. FDA Antimicrobial Drugs Advisory Committee voted unanimously to recommend use of maribavir for the treatment of refractory cytomegalovirus infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. The committee also voted unanimously to recommend use of maribavir for the treatment of refractory CMV infection and disease without genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. Both recommendations were based on the results of the Phase 2 and Phase 3 TAK-620-303 (SOLSTICE) trials.

18:04 EDT Sundial Growers to acquire Alcanna for $346M - Sundial Growers has entered into an arrangement agreement with Alcanna to acquire all of the issued and outstanding common shares of Alcanna by way of a statutory plan of arrangement for total consideration of approximately $346M. With over 25 years of experience in retailing regulated products, Alcanna is Canada's largest private liquor retailer, operating 171 locations predominantly in Alberta under its three retail brands. Alcanna's strategic partner, in which it holds an approximately 63% equity interest, Nova Cannabis, is one of Canada's largest cannabis retailers. Nova currently operates 62 stores across Alberta, Saskatchewan and Ontario. It is estimated that the transaction will deliver more than $15M of additional EBITDA on an annual run-rate basis through synergies and other strategic initiatives. Alcanna shareholders are to receive Sundial common shares in an all-stock transaction. Alcanna's shareholders will receive, for each Alcanna common share held, 10.69 common shares of Sundial, representing a deemed value of $9.12 per Alcanna Share. The transaction is expected to close in December 2021 or in 1Q22.

18:00 EDT Analog Devices director buys 8K shares of common stock - In a regulatory filing, Analog Devices disclosed that its board member Bruce Evans bought 8K shares of common stock on October 6th in a total transaction size of $1.32M.

17:33 EDT Momentive jumps 13% to $24.50 after Bloomberg report on sale deliberations

17:19 EDT Autoscope Technologies subsidiary ISNS' CEO resigning - Autoscope Technologies announced that on October 1, Chad Stelzig, President and CEO of Image Sensing Systems - ISNS -, notified the Board of Directors of Autoscope and ISNS that he was resigning. ISNS is a wholly-owned subsidiary of Autoscope. Frank Hallowell, CFO of Autoscope and ISNS, will assume the role of Interim CEO of ISNS when Stelzig's resignation is effective. Stelzig will assist in the transition of responsibilities over the coming months, and the Board will soon begin a search for Stelzig's successor.

17:04 EDT Stealth Biotherapeutics presents 'positive' SBT-272 preclinical data at NEALS - Stealth BioTherapeutics "announced the presentation of new promising data from a study evaluating the effects of SBT-272 in a murine model of amyotrophic lateral sclerosis, or ALS. The data were presented at the virtual 2021 Annual Northeast Amyotrophic Lateral Sclerosis, or NEALS, Meeting held October 6-7, 2021. This preclinical study evaluated the effects of SBT-272 on mitochondrial function, morphology, and motility in mouse corticospinal motor neurons with mutant TDP-43 pathology. Systemic administration of SBT-272 in rodents resulted in sustained SBT-272 levels across different regions of the brain and protected mitochondria against ischemic stress, confirming that the compound crosses the blood brain barrier and has mitoprotective effects. Mitochondrial motility, which was significantly impaired in TDP-43 upper motor neuron cultures, was improved in a dose-dependent manner with SBT-272 treatment. Mitochondrial ultrastructural defects associated with TDP-43 pathology were also reduced with SBT-272 treatment. The improved mitochondrial motility and ultrastructure were associated with improved axon outgrowth in cultured mutant TDP-43 neurons treated with SBT-272. These data highlight the potential of SBT-272 as a systemically administered therapy for treating neurodegenerative diseases."

16:58 EDT Molina to acquire long-term care business of AgeWell New York for $110M - Molina Healthcare announced that it has entered into an agreement to acquire the Medicaid managed long-term care business of AgeWell New York. The purchase price for the transaction is approximately $110M, net of certain tax benefits and Molina's target allocation of required regulatory capital. AgeWell is a specialty managed care organization that provides long-term care services at home or in the community for those who are chronically ill or disabled in The Bronx, New York, Queens, Kings, Nassau, Westchester and Suffolk counties. As of August 31, AgeWell served approximately 13,000 managed long-term services and supports members, with full-year 2020 premium revenue of approximately $700M. The transaction is expected to be immediately accretive to Molina's adjusted earnings per share. Molina intends to fund the purchase with cash on hand. The transaction is subject to applicable federal and state regulatory approvals and the satisfaction of other customary closing conditions. It is expected to close by Q3.

16:45 EDT Allogene Therapeutics trading resumes

16:32 EDT Babcock & Wilcox Environmental awarded $10M ash handling contract - Babcock & Wilcox's Environmental segment has been awarded a contract for approximately $10M to install ash-handling equipment that will support its customer's environmental compliance requirements. The installation work will be performed by Babcock & Wilcox Construction.

16:24 EDT Quidel CEO says SARS testing environment 'highly fluid' - CEO Douglas Bryant further states: "Due to the efforts of these teams, in the third quarter we manufactured and shipped the largest volume of tests ever produced and shipped in any quarter in Quidel's history and are also on-track to reach our target run-rate capacity of approximately 70M rapid antigen tests per month by the end of the year. Even with this incredible performance in the third quarter, we must reiterate that the SARS testing environment remains highly fluid, and we've learned that demand can change very quickly. That said, regardless of these ebbs and flows, we believe that Quidel remains well-positioned to execute on our near-term and longer-term objectives across our broader portfolio of diagnostic assays and instruments. We look forward to discussing our business, including details around product mix and demand, in more detail on our third quarter earnings call."

16:21 EDT Pzena Investment reports preliminary AUM $50.8B at September 30 - Compare to $53.1B at August 31 and $33.3B at September 30, 2020.

16:17 EDT Vaxart 's oral COVID-19 vaccine candidate shows reduced airborne transmission - A Duke University-led study published in bioRxiv showed that Vaxart's investigational oral tablet vaccine reduced the airborne transmission of SARS-CoV-2 virus in an animal model. These results are consistent with those from Vaxart's Phase II human flu challenge study, which showed that Vaxart's oral tablet vaccine was better at reducing shedding than the injectable flu vaccine comparator. The preclinical study also demonstrated that Vaxart's oral vaccine platform induces "robust" systemic and mucosal responses. Researchers vaccinated hamsters orally or intranasally with Vaxart's S-only vaccine candidate and then exposed them to significant levels of the COVID-19 virus to promote vaccine breakthrough. Vaccinated hamsters cleared infectious virus in the nose and lungs quickly. Before clearing the infection, the vaccinated hamsters were exposed to unvaccinated hamsters via aerosol. The mucosally vaccinated hamsters infected fewer hamsters and created less severe clinical symptoms than did unvaccinated hamsters. Earlier this week, Vaxart initiated recruiting for a global Phase II clinical trial of its oral tablet COVID-19 vaccine candidate, which targets the SARS-CoV-2 viral spike protein.

16:16 EDT Allogene says FDA put clinical hold on AlloCar T clinical trials - Allogene Therapeutics reported that following a report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the ALPHA2 study, the U.S. Food and Drug Administration has placed a hold on the company's AlloCAR T clinical trials. The company expects to provide additional updates in the coming weeks following consultation with the FDA. The FDA continues to actively review the end of Phase 1 materials submitted in anticipation for an ALLO-501A pivotal Phase 2 trial. "Patient safety is our highest priority, and we are committed to working closely with the FDA to evaluate any potential clinical implications of this finding, and determine next steps for advancing ALLO-501A and our clinical programs," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "As a leading developer of allogeneic cell therapies, we recognize our added responsibility to fully assess all aspects of our therapies to advance the field. We are grateful for the partnership with the patient community, clinical investigators, our Scientific Advisory Board, and the FDA as we work diligently toward understanding the clinical significance of this finding and to support the development of allogeneic CAR T therapy for cancer." The clinical hold follows the company's notification to the FDA of a chromosomal abnormality in an ALPHA2 study patient which was detected in a bone marrow biopsy undertaken to assess pancytopenia. An investigation is underway to further characterize the observed abnormality, including any clinical relevance, evidence of clonal expansion, or potential relationship to gene editing.

16:13 EDT Allogene Therapeutics trading halted, news pending

16:08 EDT Terreno Realty reports 241 owned buildings as of September 30 - Terreno Realty announced its operating, investment and capital markets activity for the third quarter of 2021. As of September 30, 2021, Terreno Realty Corporation owned 241 buildings aggregating approximately 14.1 million square feet and 31 improved land parcels consisting of approximately 114.7 acres. In addition, Terreno Realty Corporation had four properties under redevelopment that upon completion will consist of three properties with buildings aggregating approximately 415,000 square feet and one improved land parcel of approximately 4.9 acres. During the third quarter of 2021, Terreno Realty Corporation acquired ten properties consisting of eight buildings containing approximately 339,000 square feet and five improved land parcels of approximately 22.0 acres for an aggregate purchase price of approximately $167.1 million. During the third quarter of 2021, Terreno Realty Corporation issued 751,539 shares of common stock with a weighted average offering price of $66.51 per share, receiving gross proceeds of $50.0 million under the Company's at-the-market equity offering program. Year-to-date through September 30, 2021, Terreno Realty Corporation has issued 2,542,357 shares of common stock with a weighted average offering price of $63.22 per share, receiving gross proceeds of $160.7 million under the Company's at-the-market equity offering program. Terreno Realty Corporation did not repurchase any shares of common stock pursuant to the Company's share repurchase authorization.

16:07 EDT PS Business Parks names Adeel Khan as new CFO - PS Business Parks (PSB) announced that Adeel Khan has been appointed as the company's CFO and Corporate Secretary, effective January 10, 2022. Jeffrey D. Hedges will continue to serve as the company's Executive Vice President, CFO, and Corporate Secretary until November 12, 2021 and has agreed to serve as a consultant to the Company until February 11, 2022 to facilitate the transition. Mr. Khan previously served as CFO of Rexford Industrial Realty (REXR) from July 2013 through August 2020.

16:05 EDT Nkarta says patients dosed in NKX019 study for advanced B-cell malignancies - Nkarta announced NKX019 and NKX101 clinical development program updates. Patients have been dosed in the international Phase 1 clinical trial of NKX019 in advanced B-cell malignancies. NKX019 is an NK cell immunotherapy that is engineered to eradicate tumors expressing CD19, a validated B-cell cancer target. "We are excited to explore the potential of NKX019, our second clinical-stage, engineered chimeric antigen receptor NK cell therapy candidate, to become a leading treatment of B-cell malignances for eventual use in a broadly accessible outpatient setting," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "NKX019 builds upon the potent innate anti-tumor biology and promising safety profile of natural killer cells. This trial moves us one step closer to bringing game-changing, off-the-shelf cell therapies to cancer patients. We anticipate reporting initial data from the NKX019 study in 2022." Nkarta is producing the clinical supply of NKX019 at its in-house cGMP clinical manufacturing facility in South San Francisco, California. Nkarta is also updating guidance on when it expects to announce initial data from the first-in-human Phase 1 clinical trial of NKX101, an engineered CAR NK cell therapy candidate targeting the NKG2D ligand, in patients with relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes to the first half of 2022.

16:02 EDT Williams-Sonoma raises hourly minimum wage to $15 per hour - Williams-Sonoma announced that the company will increase its hourly minimum wage to $15 per hour, effective immediately.

15:38 EDT Bicycle Therapeutics reverses higher, up 4% after volatility halt - Shares of Bicycle Therapeutics, which had been down over 20% following the lifting of a trading halt after the company reported clinical data, are now up $1.68, or 4%, to $43.38 near 3:40 pm ET.

15:20 EDT Bicycle Therapeutics trading resumes

15:14 EDT CytoSorbents announces availability of preliminary abstracts from two studies - CytoSorbents announced the public availability of preliminary data abstracts from two separate endocarditis studies, including the REMOVE study, to be presented at the upcoming European Association for Cardio-Thoracic Surgery, or EACTS, annual meeting taking place in Barcelona, Spain from October 13-16, where more extensive data are expected to be made available. Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents stated, "At the current time, the available data from both studies are preliminary and limited and do not allow for in-depth evaluation. We plan to have a detailed statement once the full formal presentations are completed next week, and more complete data are made available. From a high level, CytoSorb therapy tends to work best in carefully selected patients with a high acuity of illness who are treated with the device early and for an adequate duration of time. In the case of these two endocarditis studies, important underlying differences may exist in the respective patient cohorts that could explain the reported differences in the observed benefits with the intraoperative use of CytoSorb during valve replacement surgery. In addition, in both studies, CytoSorb was only used intra-operatively, where today in many centers, CytoSorb therapy in infective endocarditis patients has advanced to be used both intraoperatively and postoperatively during recovery with reported improved benefits. Importantly, the investigators from Nuremberg reported that the intraoperative use of CytoSorb during cardiac surgery was well-tolerated and safe. We view this as a positive development that provides added reassurances for our ongoing clinical programs on intraoperative device use and are looking forward to reviewing the safety data from the REMOVE trial that we anticipate will be released during the formal presentation. We plan to work closely with the investigators of both studies to better understand the results and determine the direction for further analyses that could help identify the optimal endocarditis patient population for CytoSorb use and potentially inform the design of future endocarditis studies."

15:08 EDT Bicycle Therapeutics to resume trading at 3:20 pm ET - Bicycle Therapeutics shares are scheduled to resume trading at 3:20 pm ET, with quotation to resume at 3:15 pm ET, according to Nasdaq.

15:02 EDT Stellantis to invest $229M in three Indiana plants to accelerate EV plans - Stellantis announced it would invest a total of $229M in three of its Kokomo, Indiana, plants to help the company reach its goal of achieving 40% low-emission vehicle sales in the U.S. by 2030. "This announcement, which will retain 662 jobs, comes three months after the company laid out its long-term electrification strategy, where it committed to investing $35 billion through 2025 in electrification and software... The investment will support retooling of the Kokomo Transmission, Kokomo Casting and Indiana Transmission plants to produce the fourth-generation eight-speed transmission. This new transmission will have the flexibility to be paired with internal combustion engines, as well as mild hybrid and plug-in hybrid propulsion systems, for vehicles across the Jeep, Ram, Chrysler and Dodge brands," the company said.

14:44 EDT Capital One postpones full office reopening in U.S. - Capital One stated in a post to its corporate newsroom: "It has been 574 days since Capital One first closed its U.S. offices. Sustained progress to contain and reduce the impacts of COVID-19 in the United States has been elusive... A Delta-driven wave is still prevalent in the U.S. Infection and transmission rates remain elevated-96% of counties in the U.S. are experiencing High or Substantial rates of COVID-19 transmission. Children under twelve have yet to be approved to access vaccines. And CDC mask guidance encourages individuals to wear masks while indoors. It is for that reason that Capital One is announcing it will not reopen its U.S. offices on November 2 as previously shared. Given the continued fluid nature of the situation, a decision was also made not to attempt to forecast a specific date for a full-scale reopening of U.S. offices. Associates will be provided 30 days advance notice before any decision to fully reopen U.S. offices in 2022 - moving into a destination hybrid work approach - is made... For Capital One associates looking for in-person interactions, opportunities for connecting and reconnecting with colleagues and friends across the company will be made available, in a fully voluntary manner. It is with sincere hope that a return to life as we always knew it is just around the corner." Reference Link

14:20 EDT RPM raises quarterly dividend 5.3% to 40c per share - RPM International announced at its annual meeting of stockholders that its board of directors declared a regular quarterly cash dividend of 40c per share, payable on October 29, 2021, to stockholders of record as of October 18, 2021. This payment represents a 5.3% increase over the 38c quarterly cash dividend paid at this time last year.

13:36 EDT American Express Credit terminates commercial paper program - American Express disclosed that on October 1, American Express Credit Corporation terminated its amended and restated three-year credit agreement among the company, Wells Fargo Bank, National Association, Citibank and Deutsche Bank. The credit agreement provided American Express with a committed syndicated credit facility with a borrowing capacity of $3,500,000,000 and a maturity date of October 15. No amounts were drawn on the Credco Credit Facility at the time of its termination. Also on October 1, a new $3,500,000,000 credit facility was established with American Express Company and American Express Travel Related Services Company, as co-borrowers and co-obligors. On October 5, American Express terminated its commercial paper program, which had no outstanding obligations at the time. The company had nil commercial paper outstanding as of both June 30, 2021 and December 31, 2020. "Termination of the Credco Credit Facility and commercial paper program and the establishment of the new credit facility and commercial paper program were carried out to simplify American Express' funding and reporting structure," American Express said.

13:23 EDT AbbVie says Health Canada approves RINVOQ as atopic dermatitis treatment - AbbVie announced that Health Canada has approved RINVOQ, an oral, once-daily selective JAK inhibitor for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis who are not adequately controlled with a systemic treatment or when use of those therapies is inadvisable. RINVOQ can be used with or without topical corticosteroids. Atopic dermatitis is characterized by intense uncontrolled itching, dry skin, which becomes cracked, hardened, oozing and painful. It is estimated that up to 17% of Canadians will suffer from AD at some points in their lives. "Atopic dermatitis is a chronic inflammatory skin disease that impacts both patients and caregivers. As atopic dermatitis is common at all ages, it affects many Canadians. I have seen first-hand the debilitating impact of atopic dermatitis on patients through my research and my practice," states Dr. Kim Alexander Papp, MD, PhD, FRCPC, Probity Medical Research and K. Papp Clinical Research, Waterloo ON. "If we hope to improve patients' overall quality of life, clinicians need more tools. Having access to advanced therapies allows us to better support patients and provide them with treatment outcomes that address their unmet needs."

12:53 EDT Bicycle Therapeutics reports interim Phase I trial results for BT5528 - Bicycle Therapeutics provided a clinical update of its wholly-owned, next-generation bicycle toxin conjugates, reporting interim Phase I trial results for BT5528 and preliminary findings from the ongoing dose escalation portion of the BT8009 clinical trial. A total of 24 patients were dosed both prior to, and after, the implementation of the EphA2 mmunohistochemistry assay, with a median of seven prior lines of therapy. Amongst these patients, preliminary anti-tumor activity was observed in urothelial and ovarian cancer patients, Bicycle said in a statement. A total of two BT5528 monotherapy urothelial patients were dosed. Both were observed to have tumor reductions constituting a partial response under Response Evaluation Criteria in Solid Tumors version 1.1. A total of eight BT5528 monotherapy ovarian cancer patients were dosed. Of these eight, five were determined to be EphA2-positive based on the IHC assay. Anti-tumor activity was observed in four of the five patients, including one that constituted a partial response under RECIST version 1.1 criteria. Based on the findings from the Phase I trial, Bicycle plans to initiate expansion cohorts in urothelial and ovarian cancers as well as a basket that includes head and neck, non-small cell lung, gastroesophageal and triple negative breast cancers in 2022. The trial will enroll up to 56 patients in the initial expansion cohorts, with the ability to further expand enrollment based on the results of the initial expansion cohorts.

12:25 EDT Galaxy Gaming enters settlement agreement with former chairman, CEO, Triangulum - Galaxy Gaming announced that it entered into Settlement Agreement with its former Chairman and CEO Robert Saucier and Triangulum Partners on October 7, 2021. The Settlement Agreement is conditioned upon the Company paying Triangulum and Saucier $39.1M plus interest accrued at 2% per annum from May 6, 2021, through the date of actual payment. The Company has retained Macquarie Capital to assist it in raising funds for the settlement. The Settlement Agreement allows the Company until December 31, 2021, to complete its fundraising and pay the settlement amounts to Triangulum and Saucier. The Settlement Agreement provides broad mutual releases to the Company, the Company's officers and directors, Triangulum and Saucier related to all claims against each other. The parties agree to stay the litigation pending payment of the settlement funds. In addition, among other terms, Saucier and Triangulum have agreed not to compete with the Company for a period of five years from the date of payment of funds.

12:00 EDT Small Cap Bear 3x falls -6.1% - Small Cap Bear 3x is down -6.1%, or -$1.85 to $28.42.

12:00 EDT BP Prudhoe Bay falls -9.8% - BP Prudhoe Bay is down -9.8%, or -40c to $3.69.

12:00 EDT Tata Motors rises 15.6% - Tata Motors is up 15.6%, or $3.48 to $25.82.

11:55 EDT Alibaba up nearly 10% amid increasing attention on WallStreetBets forum - Over the last 12 hours, Alibaba is the second most mentioned stock on the WallStreetBets Reddit forum, according to data from Swaggy Stocks. Shares of Alibaba Group are up $13.54, or 9.4% to $157.64 near midday.

11:10 EDT Moderna says aware of Denmark pausing vaccines under age 18 - Moderna said it is "aware of the decision of Health Authorities in Denmark, Sweden and Finland to pause the vaccination of adolescents under the age of 18 (Denmark) and individuals under the age of 30 (Sweden and Finland)." The company added, "Moderna is aware of the very rare occurrence of myocarditis and/or pericarditis following administration of mRNA vaccines against COVID-19. These are typically mild cases and individuals tend to recover within a short time following standard treatment and rest. The risk of myocarditis is substantially increased for those who contract COVID-19, and vaccination is the best way to protect against this. A recent large analysis of 6.2 million people from the US Vaccine Safety Datalink following mRNA COVID-19 vaccination did not identify an increased safety signal for either mRNA vaccine. Similarly, a study of over 2.3 million individuals conducted in the Kaiser Permanente network identified 15 cases of myocarditis in individuals receiving a mRNA vaccine, for an observed incidence of 5.8 cases per million people following the second dose of vaccine. The Moderna COVID-19 Vaccine has demonstrated substantial benefit. The protection afforded by the Moderna COVID-19 vaccine is highly robust and has been confirmed in the real-world setting as well as large, randomized trials including the Phase 3 COVE study. We continue to closely monitor the safety of all our products, both in clinical practice and in clinical trials."

10:24 EDT Eni launches IPO process for integrated Gas & Power Retail and Renewables unit - Eni announced the IPO plan in a notice made to the Borsa Italiana. Reference Link

10:11 EDT Nam Tai Property says next hearing in IsZo court fight scheduled for November 8 - Nam Tai Property provided an update regarding the dismissal of its appeal before the Eastern Caribbean Court of Appeal in the British Virgin Islands against the judgment issued by the Eastern Caribbean Supreme Court in the High Court of Justice in the British Virgin Islands on March 3 in relation to the litigation filed by IsZo Capital LP against the company together with Greater Sail Limited and West Ridge Investment Company Limited on October 4. "A consequential hearing regarding the Dismissal was conducted on October 6, 2021 at which the Court of Appeal directed, among other things, that the company may file application(s) to the Court of Appeal within 7 days of the direction, i.e. October 13, 2021, for: conditional leave to appeal to the Privy Council; a stay pending any appeal to the Privy Council; and/or; a variation of the order of the Court of Appeal dated October 4, 2021. The hearing of the aforementioned applications is scheduled for November 8," the company stated.

10:04 EDT Cytek Biosciences introduces 25-color immunoprofiling assay - Cytek Biosciences announced the launch of a new 25-color immunoprofiling assay. The new assay includes reagents and tools to simplify the workflow from sample preparation to data analysis, offering researchers an efficient way to obtain relevant data quickly and shorten the time from biological question to answer. The Cytek 25-color immunoprofiling assay is optimized for use with Cytek's Aurora full spectrum flow cytometer equipped with violet, blue, yellow-green and red lasers and provides a turnkey solution for identifying major human immune subpopulations for T, B, NK cells, monocytes, dendritic cells, and basophils.

10:00 EDT Direxion Daily Semiconductor Bear 3X Shares falls -5.3% - Direxion Daily Semiconductor Bear 3X Shares is down -5.3%, or -38c to $6.82.

10:00 EDT Lamb Weston falls -8.6% - Lamb Weston is down -8.6%, or -$5.34 to $57.00.

10:00 EDT Credicorp rises 9.4% - Credicorp is up 9.4%, or $10.87 to $126.00.

10:00 EDT Tata Motors rises 13.5% - Tata Motors is up 13.5%, or $3.02 to $25.36.

09:57 EDT Northern Oil to ask board to increase quarterly dividend 33.3% on deal closing - As reported earlier, Northern Oil and Gas announced it has entered into a definitive agreement to acquire non-operated interests across over 400 producing wellbores located primarily in Williams, McKenzie, Mountrail and Dunn Counties, ND for a purchase price of $154M in cash, subject to typical closing adjustments. The company said: "Given the strong, low risk cash flows from the acquired properties, Northern's Management plans to submit a request to the Board of Directors for a 33.3% increase to the common stock dividend for the fourth quarter of 2021, for shareholders on record as of December 31, 2021. This anticipated increase to a dividend of 6c per common share represents a 100% increase since the initiation of a dividend program in May 2021. Under Delaware law, the Board may approve such a measure within 60 days of the record date." Nick O'Grady, CEO of Northern, added: "We remain consistent with our strategy. The focus continues on being the natural consolidator of working interests and executing with financial discipline, concentrating on cost of entry, return on capital employed and cash flow net to our shareholders. Despite purchasing the assets with cash, we still expect a 1x leverage ratio by year-end 2022. With the planned dividend increase, we will have doubled our shareholder return program in less than five months since inception."

09:47 EDT Direxion Daily Semiconductor Bear 3X Shares falls -4.7% - Direxion Daily Semiconductor Bear 3X Shares is down -4.7%, or -34c to $6.86.

09:47 EDT Lamb Weston falls -10.2% - Lamb Weston is down -10.2%, or -$6.34 to $56.00.

09:47 EDT U.S. Silica rises 8.1% - U.S. Silica is up 8.1%, or 69c to $9.17.

09:47 EDT Tata Motors rises 11.0% - Tata Motors is up 11.0%, or $2.45 to $24.79.

09:34 EDT Rada Electronic reports $24M in new business in Q3 - RADA Electronic Industries announced the receipt of $24M in new business in the third quarter of 2021. Including the previously reported $56M received during the first half of 2021, the total amount of new business received in 2021 until the end of the third quarter, amounted to $80M. This represents a 36% year-over-year growth in new business compared with the same period last year. Out of this new business, almost all are for RADA's software-defined tactical radars to be used in Active Protection Systems, counter UAV, and point defense solutions. The U.S. market accounted for 14% of the new orders and the remainder came from global markets. The APS market segment, comprising slightly over half of this reported new business, is beginning to contribute and build RADA's backlog. APS revenues are expected to start in the second half of 2022 with significant contribution in 2023 and onwards.

09:31 EDT PAVmed to acquire CapNostics, terms not disclosed - PAVmed announced a wholly owned subsidiary of the Company has entered into a definitive membership interests purchase agreement with Martin Von Dyck, the sole member and owner of North Carolina-based CapNostics, LLC, which manufactures EsophaCap, a U.S. FDA 510(k)-cleared and European CE Mark certified, non-endoscopic esophageal cell collection device which has been used in pre-commercial clinical research of esophageal precancer biomarkers at major academic medical centers. Concurrently, the Company entered into an exclusive long-term consulting agreement with Mr. Von Dyck, as well as an exclusive long-term manufacturing agreement with the EsophaCap contract manufacturer.

09:27 EDT Aileron Therapeutics presents data on ALRN-6924 - Aileron Therapeutics presented new preclinical data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2021 on ALRN-6924, currently in development as a novel, selective chemoprotective agent. The new data demonstrated ALRN-6924's activity as a radioprotective agent in preclinical mouse models of acute radiation-induced toxicity, leveraging the same mechanism of action - p53 activation and subsequent p21 upregulation as well as p21-induced cell cycle arrest - that has clinically shown protection against chemotherapy-induced toxicities. Aileron is currently developing ALRN-6924, a first-in-class MDM2/MDMX dual inhibitor, to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy's attack on cancer cells. ALRN-6924 is designed to activate p53 in normal cells, which in turn upregulates p21, which pauses cell cycle in normal, healthy, proliferating cells but not in p53-mutated cancer cells. In the AACR-NCI-EORTC poster titled, "The Investigational Chemoprotection Drug ALRN-6924, a Dual Inhibitor of MDMX and MDM2, Shows Potential for Radioprotection," Aileron presented the results of preclinical studies designed to evaluate whether p53 activation with ALRN-6924 may protect healthy, proliferating cells in normal tissues from radiation-induced cellular toxicity. In a non-lethal radiation exposure model, mice were exposed to a single dose of abdominally targeted radiation at 15 Gy following one or more doses/schedules of ALRN-6924 or placebo and then monitored for body weight. Aileron evaluated serum levels of macrophage inhibitory cytokine-1, a biomarker of p53 activation, as well as biomarkers of p53-mediated cell cycle arrest, and of apoptosis in mouse bone marrow and GI tract tissue. Repeated doses of ALRN-6924 administered every eight hours yielded sustained MIC-1 elevation, which correlated with increased p21 positivity in the bone marrow and intestine, while treatment-dependent changes in cPARP expression were minimal. Additionally, mice treated with ALRN-6924 had less radiation-induced body-weight loss than untreated mice. Mice receiving one or more doses of ALRN-6924 eight hours prior to irradiation had an average of 4% body weight loss, while placebo-treated mice had 10% to 15% body weight loss five days after irradiation. Aileron is currently conducting a Phase 1b randomized, double-blind, placebo-controlled study of ARLN-6924 as a chemoprotective agent in the United States and Europe.

09:25 EDT Emerita Resources provides update on Aznalcollar court proceedings - Emerita Resources announces that the Administrative Court of Andalucia has notified the Company that it will be making a ruling in the administrative case initiated by Emerita in 2015. The application to the Administrative Court was filed by Emerita in 2015 because Emerita considered the awarding of the Aznalcollar project pursuant to the public tender process to be unfair, arbitrary and inconsistent with the well-defined rules and laws of the tender process and Spanish law. The Company perceives the Administrative Court's notice as a very positive development as Emerita's external Spanish legal counse has advised the Company that the Administrative Court has the authority to make a determination to award the Aznalcollar project to Emerita. This administrative process is separate from the ongoing criminal proceedings regarding the alleged crimes committed in the awarding of the Aznalcollar tender and this gives Emerita another path forward to obtaining the rights to the Aznalcollar project. The Company will provide details of the Administrative Court's ruling once it has been issued.

09:24 EDT Genius Brands' Kartoon Channel! launches in Spanish - Genius Brands International announced a new Spanish Language content service for children, KC! En Espanol, on its streaming platform, Kartoon Channel! This news follows Kartoon Channel!'s Tuesday announcement that it is now available on Pluto TV.

09:23 EDT Nuvalent presents new data supporting lead programs in NSCLC - Nuvalent provided new preclinical data supporting advancement of its parallel lead programs in non-small cell lung cancer. NVL-520, a ROS1-selective inhibitor, and NVL-655, an ALK-selective inhibitor, were specifically designed to solve for the dual challenges of kinase resistance and selectivity which limit the activity and durability of currently available cancer therapies. The data are available via three on-demand "short-talk" posters at the 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics, which runs from Oct. 7 through Oct. 10. The presentations detail additional preclinical evidence that NVL-520 and NVL-655 1) were active against both wild-type and various known resistance variants of ROS1 or ALK, respectively; 2) were brain-penetrant with the potential to address brain metastases; and 3) selectively inhibited their targets compared to the structurally related tropomyosin receptor kinase B, thereby minimizing the potential for off-target TRKB-related central nervous system adverse events.

09:22 EDT Bank7 to acquire Cornerstone Bank - Bank7 has entered into a definitive agreement to acquire Cornerstone Bank and its parent company. Cornerstone has assets of $241M, total deposits of $215M, and total loans of $116M as of June 30. As of June 30, the combined institutions would have approximately $1.4B in assets. The transaction is expected to close in Q4. After closing, Bank7 will operate 12 branches in Oklahoma, Texas, and Kansas. The board of directors of both parties have unanimously approved the definitive agreement. The closing of the acquisition is subject to satisfaction of customary closing conditions, including regulatory approvals and approval of the seller's shareholders.

09:20 EDT Medicenna Therapeutics presents MDNA11 data from IND-enabling studies - Medicenna Therapeutics announced the presentation of new preclinical data from its MDNA11 program in a virtual poster session at the AACR-NCI-EORTC Virtual International Conference On Molecular Targets and Cancer Therapeutics. Data presented in the poster and corresponding abstract are from murine and IND-enabling non-human primate studies of MDNA11, Medicenna's selective, long-acting and novel IL-2 super-agonist. Murine studies evaluated the anti-tumor activity of MDNA11 as monotherapy and in combination with anti-PD1 checkpoint inhibition in MC38 tumor model. NHP studies evaluated the safety, pharmacokinetics, and pharmacodynamics of three repeated doses of 0.15 mg/kg, 0.3 mg/kg, or 0.6 mg/kg MDNA11, with each dose intravenously administered 14 days apart. Key data and conclusions presented in the poster and corresponding abstract include: NHP studies: Dose proportional increases in exposure as measured by both Cmax and area under the curve were observed with increasing doses of MDNA11. Serum levels of MDNA11 generally were near or reached the lower limit of quantification within 4-5 days after dosing, with PD effects lasting more than 7 days after dosing. MDNA11 preferentially induced durable proliferation and expansion of anti-cancer immune effector cells, with limited stimulation of pro-tumor Treg cells. MDNA11 exhibited a favorable safety profile. No signs of cytokine release syndrome or anti-drug antibodies were observed at any dose level. No clinical or histological evidence of pulmonary edema or vascular leak syndrome was observed at any dose level. The main safety observations were loss of appetite, reduced activity, and diarrhea, which was observed at the highest dose level and were also transient in nature. Murine studies: Treatment with MDNA11 alone or in combination with anti-PD-1 therapy led to tumor growth inhibition and durable complete responses in a murine MC38 tumor model even though tumor growth was not inhibited by anti-PD-1 monotherapy. Initial treatment with MDNA11 alone or in combination with anti-PD-1 protected against subsequent tumor re-challenge by inducing long-term, antigen-specific CD8+ T-cells. The virtual poster presentation titled, "MDNA11 is a Long-Acting 'Beta-Only' IL-2 Agonist that Demonstrates a Safe and Durable Anti-tumor Immune Response" is available for on-demand viewing on the AACR-NCI-EORTC conference website will be available on the "Events and Presentations" page of Medicenna's website. MDNA11 is currently being evaluated in patients with advanced solid tumors in the Phase 1/2 ABILITY study. A preliminary update on safety, PK/PD, and biomarker data from early cohorts of patients enrolled in the dose escalation phase of the study this year is expected by the end of calendar 2021. A preliminary efficacy update from the study is expected in the first half of calendar 2022.

09:19 EDT Osmotica Pharmaceuticals announces debt financing from Athyrium - Osmotica Pharmaceuticals announced that it has entered into a note purchase agreement for up to $100 million of senior secured notes with funds managed by Athyrium Capital Management. Subject to the satisfaction of certain conditions, at closing of the agreement, Osmotica will issue $55 million of senior secured notes. An additional $20 million of notes will be available to Osmotica at its option by October 2022 subject to the achievement of minimum Upneeq revenues. An additional $25 million of notes could be available to the Company at Athyrium's discretion. The notes mature in October 2026.

09:16 EDT Prelude Therapeutics announces presentations of data from multiple programs - Prelude Therapeutics announced the presentation of data from multiple pipeline programs, including the dose escalation portions of the Company's ongoing Phase 1 trials of lead oral protein arginine methyltransferase 5 inhibitors PRT543 and PRT811. Kris Vaddi, Ph.D., Chief Executive Officer, said, "We are leveraging insights from these data as we move forward through the expansion cohorts in selected patient populations, and we anticipate a cadence of data from these cohorts throughout 2022." Vaddi added, "With respect to PRT2527, our potent and selective CDK9 inhibitor... We remain on track to submit an IND application and initiate a Phase 1 clinical trial by year-end." PRT543. Title: A phase 1 dose-escalation study of protein arginine methyltransferase 5 (PRMT5) inhibitor PRT543 in patients with advanced solid tumors and lymphoma. As of an August 6, 2021 data cutoff date, the dose escalation portion of the ongoing Phase 1 trial of PRT543 enrolled a total of 49 patients across 18 unselected advanced solid tumors and lymphoma. PRT543 demonstrated target engagement and inhibition of PRMT5 functional activity as evidenced by a 69% reduction in serum symmetric dimethylarginine at a dose of 45 mg/5x per week. In addition, PRT543 demonstrated signs of preliminary clinical activity, including a durable complete response maintained for over 18 months in a patient with HRD+ ovarian cancer who remains on treatment, and prolonged stable disease persisting for over six months in five patients, including four patients with adenoid cystic carcinoma and one patient with uveal melanoma. PRT543 was generally well tolerated: the most common grade 3 or higher treatment-related adverse events occurring in at least 5% of patients were thrombocytopenia and anemia, both of which were reversible upon treatment interruption. PRT811. Title: A phase 1 dose-escalation study of protein arginine methyltransferase 5 brain-penetrant inhibitor PRT811 in patients with advanced solid tumors, including recurrent high-grade gliomas. As of an August 13, 2021 data cutoff date, the dose escalation portion of the ongoing Phase 1 trial of PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, enrolled a total of 45 patients. PRT811 demonstrated dose dependent inhibition of PRMT5 activity as evidenced by an 83% reduction in serum sDMA at a dose of 600 mg daily. In addition, PRT811 demonstrated signs of preliminary clinical activity, including an IDH1 mutated GBM patient who experienced a partial response that evolved into a durable CR for more than 13 months and remains on treatment. PRT811 was generally well-tolerated; the most common grade 3 or higher treatment-related AE was thrombocytopenia, which was reversible upon treatment interruption. Patients were largely able to remain on therapy with few AE-related dose interruptions, reductions, or discontinuations. The study remains ongoing, and the Company expects to commence enrollment in the expansion portion of the trial in the fourth quarter. Data from the expansion cohorts are expected to be presented at medical meetings throughout 2022. Preclinical Data. Title: PRT2527 is a potent and selective CDK9 inhibitor that demonstrates anti-cancer activity in preclinical models of hematological malignancies and solid tumors with MYC amplification. This study sought to assess PRT2527, which is designed to be a potent and selective CDK9 inhibitor, in preclinical models of multiple hematological malignancies and solid tumors. Treatment with PRT2527 was shown to deplete oncogenic drivers with short half-lives such as MYC and MCL1 and induce apoptosis. The Company remains on track to submit an Investigational New Drug application for PRT2527 and initiate a Phase 1 clinical trial by the end of the year.

09:15 EDT Immunotherapeutic capacity of IMV's DPX delivery platform featured at AACR - IMV announced that the immunotherapeutic capabilities of its DPX delivery platform will be featured in two e-poster presentations at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics October 7-10. "Collectively, these data demonstrate the versatility and potential of the DPX delivery platform to educate robust, targeted T cell responses to distinct cargo," said Jeremy Graff, Ph.D., Chief Scientific Officer at IMV. "More specifically, the first presentation provides compelling evidence that the DPX technology triggers a more consistent and persistent immune response than conventional emulsions. The second presentation provides the scientific basis for the clinical pursuit of DPX-SurMAGE, a new IMV asset designed to simultaneously elicit immune responses to the survivin and MAGE-A9 proteins, both of which have been implicated in bladder cancer progression."

09:14 EDT Avalon GloboCare, BOKU co-develop in-silico system for drug development - Avalon GloboCare announced co-development of a novel, cell-free, in-silico system to facilitate the Company's drug development efforts, together with the Institute for Synthetic Bioarchitectures at the University of Natural Resources and Life Sciences in Vienna, Austria. A study of the new technology was featured in the September 2021 issue of Membranes, an international, peer-reviewed journal. The new technology reveals that difficult-to-study cell membrane proteins can be efficiently expressed in a cell-free system, allowing for their evaluation as potentially druggable targets. The technology expands Avalon's ability to design and produce novel membrane proteins-including receptors found on the surface of immune cells and cancer cells that are important for cell signaling and diseases such as cancer-providing Avalon an efficient tool to screen and optimize potential therapeutic targets. Proteins function within cells and are also present on cell surfaces, embedded within the cell's outer membrane. These membrane proteins include cell surface receptors that function in cell signaling and regulation of communication with other cells and tissues. These molecules are important drug targets and include receptors on immune cells such as T-cells for the development of cellular immunotherapies. The researchers used computer-based models, developed at the University of Vienna, to identify factors that optimize the expression of membrane proteins in a cell-free, in-silico system, resulting in high protein yield. The study demonstrated the success of this method by showing the ability to manipulate and express a drug target membrane protein, a human voltage-dependent anion channel, at high yield. The use of this novel technology can improve knowledge about receptors and other membrane proteins to better understand the biology of drug targets and to develop novel therapies, including immunotherapies for cancer. The new technology is a direct result of a collaboration between the Company and researchers at BOKU, Vienna, the University of Vienna, the Science for Life Laboratory within the Division of Nanobiotechnology at the KTH Royal Institute of Technology in Stockholm, Sweden and the Department of Biochemistry at the King Abdulaziz University in Jeddah, Saudi Arabia.

09:11 EDT Essa Pharma presents preclinical data on prostate cancer candidate EPI-7386 - Essa Pharma announced the presentation of preclinical data characterizing the mechanism of action of EPI-7386, Essa's lead product candidate for the treatment of prostate cancer. The data include the results of nuclear magnetic resonance studies which confirm the binding of the compound to the N-terminal domain of the androgen receptor, a region not currently targeted by other antiandrogen therapies. The preclinical data confirm EPI-7386's target engagement with the NTD of the AR through multiple studies. The company believes that the data demonstrates that the combination of EPI-7386 with enzalutamide results in complete inhibition of genome-wide androgen-induced AR binding, supporting the rationale for the company's upcoming Phase 1/2 combination trials of EPI-7386 with approved antiandrogens in patients with metastatic castration-resistant prostate cancer.

09:10 EDT Virginia Housing renews contract for Black Knight's MSP servicing system - Black Knight announced that Virginia Housing has renewed its contract to use the industry-leading MSP servicing system from Black Knight. Virginia Housing has been a valued Black Knight client for 25 years. Through its continued use of MSP, Virginia Housing will be equipped to further automate its processes and support residents within the state. The agency will also add Black Knight's Loss Mitigation solution to support deeper automation in its loss mitigation processes. With over 1M loans expected to exit forbearance in the next four months nationwide, this solution will help Virginia Housing better support its customers.

09:09 EDT JanOne unit awarded recycling contracts in Pennsylvania worth $20M - ARCA Recycling, Inc., a wholly owned subsidiary of JanOne, was recently awarded multiple contracts to operate appliance recycling programs in the state of Pennsylvania through 2026. ARCA Recycling works in partnership with several major electric utility companies in the state and ARCA aims to recycle over 30,000 refrigerators and freezers from the state annually. ARCA estimates the total value of contracts awarded in Pennsylvania to be approximately $20M over the next five years.

09:08 EDT Palo Alto Networks partners with Ingram Micro for cybersecurity solution - Palo Alto Networks has signed an agreement with Ingram Micro, a provider of technology and supply chain services, for Ingram Micro to distribute the Palo Alto Networks Okyo Garde cybersecurity solution to its resellers and technology solutions providers, who will bring Okyo Garde to small businesses across the U.S. On September 10, Palo Alto Networks announced Okyo Garde, a new cybersecurity offering that combines hardware, software and security services into one subscription, delivered through a Wi-Fi 6 system, for small businesses and workplaces. Starting in October, Ingram Micro will offer Okyo Garde for small businesses to its established and growing network of channel partners in the U.S. focused on this segment.

09:07 EDT Skye Bioscience appoints Rhea Williams as head of regulatory affairs - Skye Bioscience has strengthened its management team with the appointment of Rhea Williams, MPH, as Head of Regulatory Affairs & Quality Assurance and Varun Khurana, PhD, as Senior Director of Research & Development. Ms. Williams held management positions at Johnson & Johnson, Schering-Plough, and Eisai, and supported large and small pharmaceutical companies as a consultant. Dr. Khurana served as Principal Scientist at GlaxoSmithKline, where he was responsible for creating, leading, and driving innovation to strengthen GSK's product portfolio.

09:05 EDT Amgen reports Phase 1b data from Lumakras combination in cancer - Amgen announced new combination study results from the Phase 1b CodeBreaK 101 study, a comprehensive global master protocol trial evaluating the safety and efficacy of Lumakras in more than 10 different investigational combination regimens for the treatment of patients with KRAS G12C-mutated cancers. Results from two arms of the study will be presented at during the 2021 Virtual International Conference on Molecular Targets and Cancer Therapeutics on Oct. 9. The Lumakras and afatinib combination's objective response rate was 20% in cohort 1 and 35% in cohort 2, and the disease control rate was 70% and 74% in the two cohorts, respectively. The most common treatment-related adverse events for this study were diarrhea, nausea, and vomiting. TRAEs of grade 3 occurred in 30% of patients in both dose groups with diarrhea being the most common. In CodeBreaK 101, the combination of Lumakras and trametinib showed antitumor activity in heavily pre-treated patients with KRAS G12C-mutated solid tumors. In patients with CRC who were KRASG12C inhibitor naive, 9% achieved partial response and 82% achieved disease control. In patients who were previously treated with a KRASG12C inhibitor, 14% achieved partial response and 86% achieved disease control. The most common TRAEs for this study were diarrhea, rash, dermatitis acneiform, nausea and vomiting. No new safety concerns were identified.

09:04 EDT Tetra Tech adds $400M to share repurchase agreement - Tetra Tech announced that its Board of Directors has authorized an additional $400M share repurchase program, which is twice the size of the previous authorization. Together with the amount remaining under the previously approved program at the end of the third quarter of fiscal 2021, the Company has a total of $563 million available for share repurchases.

09:03 EDT Alteryx acquires Hyper Anna, terms not disclosed - Alteryx announced that it has acquired Hyper Anna, a cloud platform for generating artificial intelligence-driven automated insights from data. Hyper Anna is a Sydney, Australia-based company that enables anyone, regardless of technical background, to access AI-driven insights. The acquisition of Hyper Anna will allow Alteryx to automate the end-to-end analytic pipeline from data sources to AI-driven insights.

09:02 EDT Y-mAbs' 177Lu-omburtamab-DTPA granted RPDD by FDA - Y-mAbs Therapeutics announced that the U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation, RPDD, for the company's lutetium labelled omburtamab antibody program for the treatment of medulloblastoma. 177Lu-omburtamab-DTPA, a monoclonal B7-H3 antibody that has been radiolabeled with lutetium-177, is currently in a multicenter Phase 1 clinical trial in pediatric patients with refractory medulloblastoma, and in a multicenter Phase 1 clinical trial targeting B7-H3 positive CNS/LM tumors in adults. "The RPDD makes us eligible for a Priority Review Voucher upon potential approval of the biologics license application for this rare pediatric cancer. Among our leading compounds under development, four now have RPDDs, and this designation for 177Lu-omburtamab-DTPA further increase our chances of ultimately receiving multiple PRVs," said Thomas Gad, founder, Chairman and President.

08:59 EDT Relay Therapeutics announces preclinical data on RLY-2608 - Relay Therapeutics shared preclinical data at the virtual AACR-NCI-EORTC Molecular Targets Conference for RLY-2608, the first allosteric, pan-mutant and isoform-selective PI3Kalpha inhibitor. The data presented at the conference show that in preclinical models, RLY-2608 preferentially binds mutant PI3Kalpha at a novel allosteric site discovered by the Dynamo platform. Scientists at Relay Therapeutics solved the full-length structure of PI3Kalpha, performed long time-scale molecular dynamic simulations to elucidate differences in motion between wild-type and mutant PI3Kalpha, and leveraged these insights to enable the design of RLY-2608. In biochemical and cellular assays, RLY-2608 inhibited the three major classes of PI3Kalpha oncogenic mutations while sparing WT PI3Kalpha. The data further suggest that RLY-2608 is also highly selective against other PI3K family members and exquisitely selective across the kinome. The data suggest that projected clinically relevant doses of RLY-2608 achieved tumor regression in PIK3CA mutant in vivo xenograft models representing H1047R and E545K mutations with significantly reduced impact on glucose metabolism compared to non-mutant selective active site inhibitors. In higher species, dosing of RLY-2608 resulted in exposures exceeding 90% inhibition of mutant PI3Kalpha in cells without resulting in elevated glucose levels or histopathological changes associated with dysregulation of glucose metabolism that are seen with non-mutant selective inhibitors. These results support advancement of RLY-2608 into clinical development as a differentiated mechanism of mutant PI3Kalpha inhibition with the first-in-human study anticipated to start in the first half of 2022. RLY-2608 is the lead program of multiple preclinical efforts at Relay Therapeutics to discover and develop mutant selective inhibitors of PI3Kalpha. RLY-2608 has the potential to address over 100,000 patients per year in the United States, one of the largest patient populations for a precision oncology medicine. Selectivity for all three mutation hot spots has the potential to effectively double the addressable patient population compared to selectivity for only H1047X.

08:51 EDT AstraZeneca treatment of eosinophilic esophagitis granted orphan status - AstraZeneca's tezepelumab was granted orphan status from the FDA as a treatment of eosinophilic esophagitis, according to a post to the agency's website. Reference Link

08:46 EDT LiveOne's LiveXLive surpasses 1.25 million paid subscribers - LiveOne provided certain updated metrics for its business operations. LiveOne stated that it "continues to experience growth in nearly every facet". PodcastOne has added more than 50 new advertisers since July 2020. Total social media reach across the exclusive talent roster of PodcastOne now exceeds 280 million. LaunchPadOne, PodcastOne's original podcast hosting platform, made its global relaunch in July 2021. PodcastOne saw 50% growth in monthly traffic; PodcastOne had over 2.38 billion podcast downloads; LiveXLive's Audio Listens topped 64 billion since inception; PPVOne combined with ReactOne generated over $25M in ticketed events sales: sold over 60,000 tickets with over 25,000 new LiveXLive subscribers and over 1 million livestreams for B.I PPV and Spring Awakening Music Festival: Autumn Equinox; and social media channels grew 44% in 2021.

08:42 EDT OSI Systems gets $200M U.S. CBP order for screening technology - OSI Systems announced that its Security division was recently awarded an indefinite delivery, indefinite quantity contract by the U.S. Customs and Border Protection for low-energy portal x-ray systems. The multiple vendor IDIQ contract has a potential value of up to $390M and contains a five-year ordering period for systems and associated services. This is in addition to the previously announced $480M multi-energy portal IDIQ contract. Under the LEP and MEP IDIQ contract awards, the Company received two delivery orders totaling approximately $200M. The Company could potentially receive up to an additional $65M under these orders if the CBP exercises its options.

08:42 EDT InterDigital, Zip Code announce outcomes of B1ue N0te - Zip Code Wilmington, in partnership with InterDigital, launched B1ue N0te in late 2020 and are now releasing outcomes of the program. The B1ue N0te initiative exceeded program expectations by training nearly 200 Delaware high school juniors and seniors during the 2020-2021 school year and summer camp. Designed to provide industry-standard computer programming and web development training to local students, B1ue N0te attracted underrepresented and socioeconomically disadvantaged youth to learn technical skills. The goal of B1ueN0te is to give Delaware high school students the technical skills that could interest them in pursuing further education in STEM fields or additional training toward high-paying software development jobs after graduation. "We are proud to see our vision for B1ue N0te come to life and give under-resourced students the opportunity to access technical knowledge and skills that give them an early start at a rewarding career after high school graduation," said Liren Chen, President and CEO of InterDigital. "We are bridging the tech skills gap early in the learning continuum with the help and expertise of Zip Code Wilmington's world-class curriculum and instructors. We look forward to our continued partnership and implementing B1ue N0te in more schools in Delaware in the years to come." Each school deployed the B1ue N0te program in different ways. While the gender and BIPOC makeup of each class differed based on the school or summer camp setting, overall, the class demographics demonstrated upwards of 33 percent female, 44 percent African American, 31 percent Latinx, and 25 percent disabled, in various combinations.

08:39 EDT Ballard Power and HDF Energy begin construction of baseload hydrogen power plant - Ballard Power partner Hydrogene de France - HDF Energy -, an Independent Power Producer dedicated to renewable power generation, commenced construction of the CEOG Renewstable Power Plant in French Guiana. CEOG is the world's first multi-megawatt, baseload hydrogen power plant, and the largest green hydrogen storage of intermittent renewable electricity sources. Also, CEOG is the first order for a new generation of megawatt power fuel cell systems dedicated to stationary applications, which will be mass produced in the HDF facility in Bordeaux. This project is part of a multi-staged development agreement between Ballard and HDF. CEOG is the first commercial project for HDF under this agreement. The $200M French Guiana CEOG project will combine a solar park, long-term hydrogen and short-term battery storage and fuel cells specified by HDF, based on Ballard's ClearGen architecture. HDF and Ballard anticipates the two 1.5 MW fuel cell systems, to be delivered by mid-2023.

08:38 EDT Weber opens European-based manufacturing/distribution hub in Zabrze, Poland - Weber announced it has officially opened its European-based manufacturing and distribution hub. Weber's new BREEAM-certified facility, located in Zabrze, Poland, improves the Company's ability to meet fast-growing product demand within the Region. Weber will celebrate the grand opening of this facility with an on-site ribbon-cutting ceremony tomorrow, October 8. "Our new manufacturing and distribution center marks an important milestone in Weber's global expansion and European growth," said Chris Scherzinger, Chief Executive Officer of Weber. "A key element of our growth plans includes our 'Make-Where-We-Sell' strategy. This approach focuses on manufacturing high-quality Weber barbecue products closer to our retail customers and consumers, improving our delivery and service speed. We also gain considerable efficiencies operationally and a new level of flexibility to respond and react to local market dynamics and needs."

08:37 EDT Herc Holdings to buy Toronto-based Rapid Equipment in accretive deal, no terms - Herc Holdings announced that it has entered a purchase agreement to acquire Toronto-based Rapid Equipment Rental Limited . The transaction is subject to customary closing conditions with a plan to close in the fourth quarter of 2021. Terms were not disclosed. Rapid Equipment, a full-service general equipment rental company founded in 2013, comprises approximately 110 employees and seven locations serving construction and industrial customers throughout the Greater Toronto Area - one of the largest equipment rental markets in North America. "We expect the acquisition to be accretive to earnings in the first year. We remain well positioned to pursue growth through acquired operations, greenfield branches and investment in key fleet categories as we continue to seek improved scale, profitability and shareholder returns."

08:36 EDT Acer Therapeutics, Relief receive notice of allowance for US patent application - Acer Therapeutics (ACER) and its collaboration partner, RELIEF THERAPEUTICS (RLFTF) announced that the U.S. Patent and Trademark Office, or USPTO, has issued a Notice of Allowance for Acer's patent application No. 17/196,416 for certain claims related to ACER-001. The allowed patent claims in the application titled, "Palatable Compositions Including Sodium Phenylbutyrate and Uses Thereof," include pharmaceutical composition claims covering ACER-001's taste-masked, multi-particulate dosage formulation for oral administration. Acer's patent is expected to be issued in the fourth quarter of 2021 and expire in 2036. If it receives marketing approval for ACER-001, Acer intends to submit the patent for listing by the U.S. Food and Drug Administration in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. "We are extremely pleased to have received this Notice of Allowance from the USPTO for our proprietary formulation of ACER-001 as we continue to advance its development to potentially treat patients with Urea Cycle Disorders, Maple Syrup Urine Disease and other possible indications," said Jeff Davis, Chief Business Officer at Acer. "This Notice marks another important milestone in our pursuit of possible ACER-001 commercialization while we prepare to bring this treatment to UCDs patients, subject to FDA's approval of our ACER-001 New Drug Application."

08:35 EDT SuperCom wins $1M rehabilitation project in Central Coast California - SuperCom, through its fully-owned subsidiary, Leaders in Community Alternatives, has been awarded a new project with a probation department in Central Coast California to provide rehabilitative services. This project supports those reentering the community from periods of incarceration by providing services that contribute to a reduction in recidivism. This new project is valued at approximately $1M over a term of three years, or approximately $340K per year, and is expected to launch and start generating recurring revenue before the end of 2021.

08:34 EDT Ovid Therapeutics appoints Kevin Fitzgerald to board of directors - Ovid Therapeutics (OVID) announced that it has appointed Kevin Fitzgerald, Ph.D., to its Board of Directors. Fitzgerald has over 20 years of drug discovery experience and currently serves as the Chief Scientific Officer, Senior Vice President and Head of Research at Alnylam Pharmaceuticals (ALNY).

08:33 EDT Altisource announces definitive agreement to sell Pointillist for $150M - Altisource Portfolio Solutions announced that the shareholders of Pointillist, a majority owned subsidiary of Altisource, entered into a definitive agreement to sell all of the equity interests in Pointillist to Genesys Cloud Services for $150M. The Purchase Price consists of an up-front payment of $145M, subject to certain adjustments at closing, including a working capital adjustment, and an additional $5M to be held in an escrow account to satisfy certain Genesys indemnification claims that may arise on or prior to the first anniversary of the sale closing, with the balance to be paid thereafter. On a fully diluted basis, Altisource owns approximately 69% of the equity of Pointillist. The company estimates that it will receive approximately $100M in cash at closing, subject to a working capital adjustment, and an additional $3.7M in cash following the one-year anniversary of closing, assuming no indemnification claims. Altisource estimates it will recognize a pre-tax and after-tax gain of approximately $107M from the sale which is anticipated to close before the end of the 2021 calendar year. The sale is subject to customary closing conditions including the receipt of regulatory consents. "We are pleased to execute the definitive agreement to sell Pointillist to Genesys. We believe this transaction demonstrates that Altisource has a collection of valuable businesses that may not be fully appreciated by the capital markets. Monetizing this attractive asset strengthens Altisource's balance sheet by adding $100 million of cash at closing and aligns Pointillist with a strategic partner to help accelerate its growth. I'd like to thank the Pointillist team and wish them the best in the next phase of Pointillist's evolution," said Chairman and Chief Executive Officer William Shepro.

08:32 EDT Phunware to build Headlines+ website, mobile applications for Intermarkets - Phunware announced that it will design, build and support the new Headlines+ website and mobile application portfolio for Intermarkets, Inc.Based just outside of Washington, DC and founded in 1997, Intermarkets connects publishers, advertisers and consumers through its portfolio of premium digital services. Intermarkets works closely with publishers to not only provide premium market representation and revenue opportunities, but also promote free speech across the internet. Intermarkets' content aggregation service, Headlines+, will partner with independent content creators to curate and deliver top stories in politics, entertainment, sports and more. Intermarkets has licensed Phunware's Multiscreen-as-a-Service platform in order to deliver a unified and engaging Headlines+ experience for readers on Apple iOS, Google Android and Web. These applications will feature news aggregation from Headlines+ content partners and in-app monetization opportunities through digital advertising. Phunware will also develop HTML and JavaScript widgets so content partners can display the Headlines+ news feed on their websites.

08:31 EDT Exxon Mobil raises Stabroek resource estimate to 10B barrels - ExxonMobil increased its estimate of the discovered recoverable resource for the Stabroek Block offshore Guyana to approximately 10B oil-equivalent barrels. The updated resource estimate includes a new discovery at the Cataback-1 well, which brings the total significant discoveries to more than 20 within the Stabroek Block. The Cataback-1 well encountered 243 feet of net pay in high quality hydrocarbon bearing sandstone reservoirs. It is located approximately 3.7 miles east of Turbot-1 and was drilled in 5,928 feet of water by the Noble Tom Madden. "This discovery adds to the resource in the Turbot/Tripletail area, enhancing the development project potential," said Mike Cousins, senior vice president of exploration and new ventures at ExxonMobil. "Our proprietary technologies, global exploration experience and drilling capabilities continue to yield positive results in the Stabroek Block, which will generate additional value for Guyana." ExxonMobil's recent discoveries and ongoing projects continue to contribute to the advancement of the Guyanese economy, with more than 2,850 Guyanese now supporting the company's project activities. ExxonMobil and its key contractors have spent over $480M with more than 800 Guyanese vendors since 2015. bil

08:29 EDT Avid Bioservices appoints Matthew Kwietniak as Chief Commercial Officer - Avid Bioservices (CDMO) announced the appointment of Matthew Kwietniak as chief commercial officer. In his new role, he will be responsible for continuing the current growth trajectory of Avid's CDMO business through the ongoing expansion of the company's commercial and clinical client base. Kwietniak most recently served as head of drug product sales for the Americas within the pharma services group at Thermo Fisher Scientific (TMO).

08:27 EDT BioCardia announces first cross-over patient treated in CardiAMP trial - BioCardia announced the treatment of the first cross-over patient in the ongoing Phase III Pivotal CardiAMP Cell Therapy in Heart Failure Trial for the treatment of ischemic heart failure. A cross-over patient is one who was previously in the control group of the study, has completed follow-up, and elects to receive therapy. A protocol amendment approved by the FDA allows patients in the trial who were initially randomly assigned to the control arm and did not receive therapy to elect to cross-over and receive the investigational autologous CardiAMP Cell Therapy after completing the two-year follow-up. The approval of the study's cross-over arm was based in part on the study's Data Safety Monitoring Board's formal assessments during the trial. The amendment also included provisions for following cross-over patients for a period of one additional year under the clinical protocol.

08:25 EDT Beam Global receives first US Marine Corps order for EV ARC charging systems - Beam Global announced that the U.S. Marine Corps has placed a first order for 21 EV ARC solar-powered EV charging systems to be deployed across 14 Marine Corps bases in the continental U.S. and Hawaii to support Executive Order 14008 on Tackling the Climate Crisis at Home and Abroad. The systems were purchased through the General Services Administration, or GSA, Multiple Award Schedule, MAS, Contract Number 47QSWA21D0006. The Marine Corps' EV ARC systems are off-grid and powered by renewable energy, generating and storing their own clean electricity. Each system is equipped with two EV chargers that are factory integrated at Beam and is delivered as a turnkey sustainable charging system that can power EVs, day or night, and during inclement weather and power outages. The transportable but permanent units include the Emergency Power Panel option for use during blackouts or in locations where there is no utility connection available. Requiring no connection to the utility grid, EV ARC systems also serve as energy resiliency and energy security assets that can be relocated to charge vehicles in the event of power failures, natural disasters or emergency situations. "The Federal Government is affirming that the electrification of transportation in the U.S. is vital to improving our economy, competitive position, national security and public health. EV ARC systems are the fastest deployed and most scalable sustainable EV charging infrastructure solution and require no construction, no electrical work and generate no utility bill," said Beam Global CEO Desmond Wheatley. "Beam is a proud employer of veterans. We've had a lot of retired marines working to produce our products. Now we're delighted to support their active-duty brothers and sisters in arms with reliable American invented and American made EV charging infrastructure products."

08:24 EDT Verizon, LA Unified partner to provide connectivity in Florida - To help narrow the digital divide in California and address the need for reliable internet access, Verizon and the Los Angeles Unified School District have expanded their existing partnership to provide eligible families with access to mobile broadband plans, voice service plans, and equipment through state, local, or non-profit organizations in California.

08:23 EDT Science 37, LifeSci Acquisition II close business combination - Science 37 announced that it has completed its previously announced business combination with LifeSci Acquisition II Corp. (LSAQ). Shares of common stock of the combined company, named Science 37 Holdings, Inc. will begin trading on the Nasdaq Global Market under the new ticker symbol "SNCE" today, October 7, 2021. LifeSci shareholders approved the transaction at a special meeting on October 4, 2021. As a result of the transaction, Science 37 has received approximately $235 million total cash, net of fees and expenses paid in connection with the closing of the business combination, including the proceeds from the private placement completed in connection with the transaction. Science 37 intends to use the transaction proceeds to fund its decentralized trial technology platform, extend into new adjacencies, and power the next generation in clinical research. David Coman, Chief Executive Officer of Science 37, Inc., and Science 37 Inc.'s current executive team will continue to lead the combined company. Following the business combination, David Coman will serve on Science 37's Board of Directors alongside Rob Faulkner, Managing Director at Redmile Group, as Chairman; John W. Hubbard, Ph.D., former Chief Executive Officer at Bioclinica and former Senior Vice President and Worldwide Head of Development Operations at Pfizer; Bhooshi de Silva, Senior Vice President, Global Head of Corporate Development, Strategy and Ventures, at PPD; Adam Goulburn, Ph.D., Partner at Lux Capital; Neil Tiwari, Partner of Private Healthcare Ventures at Magnetar Capital; and Emily Rollins, former Partner of Deloitte & Touche.

08:20 EDT HP Inc. announces Work From Home unified PC, print offering - HP Inc. announced a unified PC and print offering to help create a strong hybrid work foundation for enterprises and their employees. The company said, "HP Work from Home is a simple solution for IT leaders to securely and easily deploy and manage HP PCs, printers, and supplies to a distributed workforce. The HP Work from Home service includes: PC and print hardware delivered to the home or office; Supplies auto replenishment proactively schedules ink or toner delivery; Proactive insights to help manage and support your remote employees, including remote diagnostics and next-business day support4 to help reduce disruptions; Hardware-enforced protection built into select devices and an always-on, always-acting defense for remote work environments across PCs and printers so employees can work with strong security from anywhere without worry."

08:19 EDT Manhattan Associates selected by Via Varejo to improve its supply chain - Manhattan Associates announced that Via Varejo, Brazil's largest electronics and furniture retailer, has selected Manhattan Active Warehouse Management to improve its distribution operations and support its growing omnichannel business. The pilot implementation successfully completed in Q3 2021 in Contagem, MG and its remaining 25 distribution centers are scheduled to complete rollout by the end of next year.

08:16 EDT AbbVie: RINVOQ met primary, secondary endpoints in Phase 3 study - AbbVie announced positive top-line results from the first of two studies of the Phase 3 SELECT-AXIS 2 clinical trial evaluating the efficacy and safety of RINVOQ in patients with active ankylosing spondylitis who had an inadequate response to biologic DMARD therapy. In this study, RINVOQ met its primary endpoint of Assessment in SpondyloArthritis International Society 40 response and all ranked secondary endpoints at week 14.1 Significantly more RINVOQ-treated patients achieved ASAS40 response at week 14 compared to placebo. The results of SELECT-AXIS 1, a Phase 2/3 study in adult patients with ankylosing spondylitis who were naive to bDMARDs and had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs, were used to support the European Commission approval of RINVOQ for the treatment of active ankylosing spondylitis in January 2021.

08:15 EDT HP Inc. announces ISO/IEC 20243 certification for printers, cartridges - HP Inc. announced its enterprise printers and Original HP cartridges are now ISO/IEC 20243 certified. Granted by The Open Group, the ISO/IEC 20243 standard is a set of requirements and recommendations for mitigating maliciously tainted and counterfeit products. The company said, "By earning this certification, HP is ensuring its enterprise printers and Original HP cartridges follow best practices for global supply chain security throughout the product lifecycle."

08:13 EDT DraftKings, The Larry Fitzgerald Foundation renew collaboration - The start of Breast Cancer Awareness Month this October also marks the return of DraftKings' charitable initiative, Pink 'Em, which raises money for breast cancer research in collaboration with The Larry Fitzgerald Foundation. Beginning this weekend on NFL Week 5 and running each Sunday through the end of the month to NFL Week 8, customers can enter the free Pink 'Em pools where DraftKings will donate $1 for every entry. Since launching the Pink 'Em charity program in 2019, DraftKings customers have helped raise over $230,000 in the fight against breast cancer.

08:13 EDT Foothills Exploration commences geochemical survey of Wind River Basin - Foothills Exploration announced that it has engaged Geochemical Insight to execute a geochemical survey on a portion of the Company's acreage in the Beaver Creek East project located in Fremont County, Wyoming. The Company is actively engaged in the last stage of its geological and geophysical delineation for its first drilling target in the BCE prospect, which has the potential to produce from several formations. The initial drilling program will have multiple objectives in a stacked-pay environment. The Company has identified nine different formations for its proposed exploration program. The geochemical survey will begin on October 9, 2021, and the sampling, analysis and reporting of the data is expected to take approximately six weeks to complete. The BCE geochemical survey will be conducted in Townships 33N and 34N 95W in Fremont County about 15 miles southeast of Riverton, Wyoming. The objective of the survey is to document the location of oil and gas seeps over the surveyed area in order to reduce exploration risk for oil and gas by focusing drill targets on areas with hydrocarbon seeps and provide baseline environmental data of natural hydrocarbon seeps. A total of 194 soil samples will be collected at 1/6-mile intervals along 4- to 5-mile-long lines spaced 3,300 feet apart. All soil samples will be collected on foot off access roads. The samples will initially be analyzed for acid-extractable C1 through C4 hydrocarbons and samples with anomalous thermogenic C2+ hydrocarbons will be analyzed by Synchronous Scanned Fluorescence to look for aromatic hydrocarbon compositions indicative of condensate, light oil and heavy oil seeps. The Company is developing a 16,387-acre multi-stacked pay Exploration Development Area in Fremont County, Wyoming, which is highly prospective for oil and natural gas. A third-party engineering report of the Company's interest in the 16,387 acres located in the Wind River Basin, Wyoming, known as the Beaver Creek East Project, indicates Prospective Resources of approximately 21 million barrels of undiscovered oil, with a PV-10 value of $372 million. Foothills' acreage is in this large undrilled area and is along the eastern flank of a deeper sub basin in the Wind River Basin proper. Here a deep structural deposit called the Beaver Creek field has produced approximately 73.3 million barrels of oil and 934,781,606 MCF of gas. The Big Sand Draw field, updip to the south, has produced 62.0 million barrels of oil and 256,678,537 MCF of gas from multi-pay horizons. These are generally in the Frontier, Muddy, Dakota, Lakota, Morrison, Phosphoria, Tensleep and Madison formations.

08:12 EDT G1 Therapeutics announces results from analysis of three studies on COSELA - G1 Therapeutics announced results from a retrospective analysis of the pooled results of three randomized trilaciclib studies showing that patients with extensive-stage small-cell lung cancer who received the drug prior to each chemotherapy treatment had significantly lower use of supportive care therapies for chemotherapy-induced myelosuppression than patients who received placebo. Results of the retrospective analysis are published in the online edition of the journal Cancer Medicine. COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer. In the study, the researchers assessed the impact of trilaciclib versus placebo on subsequent use of supportive therapies following chemotherapy treatments for ES-SCLC. The results showed that trilaciclib significantly reduced the duration and occurrence of chemotherapy-induced severe neutropenia and the occurrence of grade 3 or greater chemotherapy-induced anemia, with a corresponding reduction in the use of supportive care therapies to manage these adverse events. Specifically, the analysis showed that administering trilaciclib prior to chemotherapy: Significantly reduced the occurrence of severe neutropenia-11.4% in the trilaciclib group versus 52.9% in the placebo group; with a corresponding reduction in G-CSF use by approximately half in the trilaciclib group compared with placebo; consistency of treatment effects on occurrence of severe neutropenia with or without concomitant G-CSF use was tested and results indicated that the effect of trilaciclib was consistent regardless of whether or not a G-CSF was administered. Significantly reduced the occurrence of grade 3/4 anemia compared with placebo-20.3% in the trilaciclib group versus 31.9% in the placebo group; with a corresponding reduction of ESA treatment: 3.3% trilaciclib versus 11.8% placebo and a corresponding reduction of red blood cell transfusions on or after week five: 14.6% trilaciclib versus 26.1% placebo. In a separate analysis, the use of trilaciclib significantly reduced patient hospitalizations due to chemotherapy induced myelosuppression or sepsis, with 4.1% of patients hospitalized in the trilaciclib arm versus 13.6% of patients hospitalized in the placebo arm. The findings were derived from a retrospective analysis of pooled data obtained from three randomized, Phase 2 clinical trials of trilaciclib or placebo administered prior to chemotherapy in 242 patients with ES-SCLC. The authors suggest that the pooled data indicate that the administration of trilaciclib prior to chemotherapy has the potential to reduce the burden of CIM on health care systems.

08:11 EDT TC Energy, Nikola sign joint development agreement for clean hydrogen hubs - Nikola Corporation (NKLA) and TC Energy Corporation (TRP) have agreed to collaborate on co-developing, constructing, operating and owning large-scale hydrogen production facilities in the United States and Canada. Nikola's Energy business unit and TC Energy are actively collaborating to identify and develop projects to establish the infrastructure required to deliver low-cost and low-carbon hydrogen at scale in line with each company's core objectives. Furthermore, Nikola and TC Energy desire to accelerate the adoption of heavy-duty zero-emission fuel cell electric vehicles and hydrogen across industrial sectors by establishing hubs in key geographic locations. A key objective of the collaboration is to establish hubs producing 150 tonnes or more of hydrogen per day near highly traveled truck corridors to serve Nikola's planned need for hydrogen to fuel its Class 8 FCEVs within the next five years. TC Energy has significant pipeline, storage and power assets that potentially can be leveraged to lower the cost and increase the speed of delivery of these hydrogen production hubs. This may include exploring the integration of midstream assets to enable hydrogen distribution and storage via pipeline and/or to deliver CO2 to permanent sequestration sites to decarbonize the hydrogen production process. Both Nikola and TC Energy are committed to reducing the carbon intensity of hydrogen produced and delivered to end-use markets utilizing renewable energy, as well as low-cost natural gas, renewable natural gas and biomass feedstocks paired with carbon capture and storage. Nikola and TC Energy are aligned in a technology agnostic approach to find the best pathway to hydrogen production for each unique geography that is intended to result in the lowest CI and a clear pathway to achieve net-zero CI over time. Nikola and TC Energy will evaluate opportunities to optimize excess hub supplies to third parties under a joint marketing and services arrangement.

08:10 EDT PolarityTE provides update on clinical hold letter from FDA on SkinTE INDA - PolarityTE provided an update regarding its Investigational New Drug Application for SkinTE with a proposed indication for chronic cutaneous ulcers submitted to the FDA in July. The company received the clinical hold letter from FDA by the previously announced date of September 21. The hold issues are certain Chemistry, Manufacturing, and Control items, which the company will have to resolve prior to proceeding with a pivotal study. The company is currently working to prepare a complete response. Additionally, PolarityTE has informally engaged with the FDA on certain points raised by the Agency regarding the proposed potency assays that the company plans to implement.

08:09 EDT Aspira, Genoox partner to deliver data-driven insights to advance women's health - Genoox and Aspira Women's Health announced a partnership to develop solutions to advance women's health with rapid results, diagnosis, and insights. Currently, the majority of genetic sequencing information can be found across multiple databases which can limit the ability for medical professionals to access and analyze this important data. Without advanced data aggregation and analytics that inform machine learning and artificial intelligence algorithms, it is more difficult to detect early-stage diseases as well as monitor and treat patients effectively. Genoox's global platform brings together information available in the public domain on one platform, allowing for the complete analysis of the data and better patient care. Aspira plans to leverage this knowledge base to expand on its proprietary algorithm development across multiple product lines. Valerie Palmieri, President and CEO of Aspira, added, "Genoox's tremendous AI and ML capabilities will enhance our data and biobank platform to expand our value proposition for our patients. Genoox and Aspira each seek to tackle the most difficult diseases in women's health, and this platform should allow us to reduce the development time for potentially groundbreaking data solutions. Additionally, with this partnership, we are one step closer to our goal of closing the gap in ovarian cancer risk assessment and developing solutions for pelvic diseases combining genomics with proteomics. We are honored to be working alongside Genoox in advancing women's health."

08:08 EDT Jones Lang LaSalle names Joe Silva as Chief Information Security Officer - JLL (JLL) announced the hire of Chief Information Security Officer Joe Silva to lead JLL's information security strategy, working closely with global technology teams across the company, including JLL Technologies, JLL's business division dedicated to commercial real estate technology. Prior to JLL, Silva worked at credit reporting agency and data analytics company TransUnion (TRU).

08:06 EDT Vinco Ventures to acquire ad-tech company AdRizer for $108M - Vinco Ventures and ZASH Global Media and Entertainment through their Joint Venture, ZVV Media Partners, has signed a binding letter of intent to acquire AdRizer, a publisher and analytics solution, for $108M. AdRizer will be integrated in the Lomotif platform for ad placement revenue similar to other technology platforms such as Google ad words and Facebook Ad Manager. The terms of the deal include: $25M in cash, with the remaining amount in equity of ZASH, common stock. The common stock will have a two-year lock up upon closing. In 2020, AdRizer reached revenues of approximately $37M. This year, AdRizer believes it is on a current run rate to achieve $62+M in revenues.

08:06 EDT iCAD to unveil next-generation technologies at JFR meeting - iCAD announced it will unveil the latest generation of ProFound AI for 2D Mammography at the Journees Francophones de Radiologie meeting in Paris, Oct. 8-11. In addition, the Company will showcase its most recent technological advancements, including the latest generations of ProFound AI for Digital Breast Tomosynthesis and ProFound AI Risk, in its booth. The latest generation of ProFound AI for 2D Mammography outperforms the previous product version, offering standalone performance improvements of up to 4% increased sensitivity, up to 10% improved specificity and up to 40% faster processing. The advanced deep-learning software uses advanced neural network image processing and pattern recognition to analyze mammography images for potential cancers. Suspicious appearing structures such as densities and calcification clusters are identified via a contoured line. Each identified region includes a Certainty of Finding score, which indicates its match to lesions within the growing ProFound AI enriched database. Each case also includes a Case Score, which indicates the algorithm's confidence level for the case matching malignant cases within the ProFound AI database. Both scores are designed to assist with clinical decision making; Case Scores may also be used to prioritize the reading worklist. Designed for seamless integration in clinical workflow, ProFound AI results can be flexibly integrated into leading MIS/RIS, and PACS software products. In addition, the new version of ProFound AI Risk will also be available for demonstration at the iCAD booth at JFR. This solution, now available for tomosynthesis, provides an accurate estimate of the risk of short-term breast cancer, which is truly personalized for each woman.

08:04 EDT Alignment, AtlaMed partner to improve care for seniors in Southern California - Alignment Health Plan, a national Medicare Advantage plan from Alignment Healthcare, and AltaMed Health Services announced a new partnership that will bolster access to care for Alignment's members in Los Angeles and Orange counties beginning Jan. 1, 2022. "With senior populations in Los Angeles and Orange counties growing exponentially, we look forward to working together with AltaMed to address disparities in health care access and improve outcomes for diverse communities," said Dawn Maroney, markets president, Alignment Healthcare and CEO, Alignment Health Plan. "As both of our organizations are based in Southern California, it is especially important to deliver on our mission to provide the highest level of care to seniors in our own communities." Alignment Health Plan members who enroll in Alignment's HMO plans in Los Angeles and Orange counties during Medicare's upcoming annual enrollment period will have access to AltaMed's 90 primary care physicians and more than 1,400 physicians, physician assistants, nurse practitioners and allied health professionals.

08:03 EDT Score Media, Penn National get Minister of Canadian Heritage approval for deal - Score Media (SCR) announced that Penn National (PENN) has received approval from the Minister of Canadian Heritage under the Investment Canada Act in connection with its previously announced acquisition of theScore by way of a plan of arrangement. Subject to approval by theScore's shareholders at a special meeting, receipt of a final order in respect of the arrangement from the Supreme Court of British Columbia, and satisfaction or waiver of the other conditions to closing contained in the arrangement agreement with Penn National, the arrangement is expected to close on October 19.

07:57 EDT Recursion Pharmaceuticals' REC-2282 granted Fast Track Designation by FDA - Recursion has been granted Fast Track designation the FDA for the investigation of REC-2282 for treatment of patients with NF2-mutated meningiomas, including neurofibromatosis type-2 disease-related meningiomas. REC-2282 is a potentially first-in-class, orally bioavailable, CNS-penetrant small molecule HDAC inhibitor being developed for the treatment of NF2-mutated meningiomas. Meningiomas are primary tumors of the meninges of the central nervous system. In the US and EU5, neurofibromatosis type-2 affects approximately 33,000 patients and there are no approved therapies.

07:48 EDT Visa expands Visa Installments to Australia - Visa announced the expansion of Visa Installments in Australia in partnership with ANZ and merchant payment provider Quest. The Visa solution lets Australian shoppers access popular "Buy Now, Pay Later," or BNPL, financing via their existing ANZ credit cards, during checkout and without any extra steps.

07:41 EDT Chart Industries SES CCC technology selected for funding from DOE - Chart Industries (GTLS) has been notified of its U.S. Department of Energy, DOE, funding award for our Sustainable Energy Solutions, SES, Cryogenic Carbon Capture, CCC, technology. With this DOE funding, our team intends to design, build, commission and operate an engineering-scale Cryogenic Carbon Capture process at Central Plains Cement's cement plant in Sugar Creek, Missouri. Central Plains Cement is a wholly-owned subsidiary of Eagle Materials (EXP). The project will scale the CCC system to a capacity of nominally 30 tonnes of CO2 per day with the intention of demonstrating that the system captures more than 95% of the CO2 from the flue gas slip stream and produces a CO2 stream that is more than 95% pure. The DOE funding for this project is $4,999,875, which was one of the four largest funding amounts out of the 12 projects included in these DOE awards, total $45M, to advance point-source carbon capture and storage technologies that can capture at least 95% of carbon dioxide emissions generated from natural gas power and industrial facilities that produce commodities like cement and steel.

07:38 EDT California's Foothill Transit orders 20 electric buses from New Flyer - NFI Group announced that its subsidiary New Flyer of America has received a new contract from Foothill Transit for 20 zero-emission, hydrogen fuel cell-electric Xcelsior CHARGE H2 forty-foot heavy-duty transit buses. This order is supported by Federal Transit Administration funds.

07:36 EDT Aehr Test Systems completes $25M ATM offering - Aehr Test System announced that it completed its previously announced $25 million "at-the-market" offering. A total of 1.7M shares were sold at an average sales price of $14.73 per share. The gross proceeds to the Company were $25M before commission fees and offering expenses. The estimated net proceeds to the Company after commission, fees, and estimated offering expenses were $24M.

07:34 EDT AerCap reports 60 aircraft leased, purchased and sold in Q3 - AerCap reported its major business transactions during Q3: the company signed lease agreements for 42 aircraft, purchased 7 aircraft and executed sale transactions for 11 aircraft from AerCap's owned portfolio. The company signed financing transactions for approximately $1.1B.

07:33 EDT Columbia Care announces Cannabist dispensary in Missouri - Columbia Care announced the first Cannabist dispensary in Missouri, located in Hermann, is now open. This marks the ninth Cannabist location and the 75th active Columbia Care dispensary in the U.S. Cannabist Hermann is located at 2060 Village Lane. "We are proud to bring the Cannabist experience to medical patients in Missouri," said Jesse Channon, Chief Growth Officer of Columbia Care. "We are seeing accelerating growth and a clear appetite for high quality products and services among an increasing number of patients in Missouri's young medical market. We're incredibly thankful to the Department of Health and Senior Services, local regulators and our business partners who have helped make this a reality as we bring the Cannabist experience to new communities across the country." The dispensary boasts seven points of sale and a drive-through service window. Columbia Care will also open a manufacturing facility in nearby Columbia, which will produce vapes, edibles, tinctures, tablets and pre-rolls. Missouri's medical marijuana sales reached more than $113M in September, since launching in October 2020. There are approximately 150,000 registered medical patients in the state. Hermann is located between Kansas City and St. Louis, the two largest population centers in the state.

07:24 EDT Monitronics announces intention to offer new senior secured first lien notes - Monitronics International announced that it intends, subject to market and other conditions, to offer $1.1B aggregate principal amount of Senior Secured First Lien Notes due 2028 in a private placement. The Company intends to use the net proceeds from the Notes offering, together with borrowings under its new credit facilities, to repay in full its existing credit facilities and to use any remaining proceeds for general corporate purposes. The Notes will be guaranteed, jointly and severally, on a first lien secured basis by each current and future wholly owned subsidiary of the Company that guarantees the Company's or any guarantor's other indebtedness. The Notes will be secured by liens on substantially all of the assets of the Company and the guarantors of the Notes.

07:19 EDT Gilat signs service agreement of $16M for operating transport networks in Peru - Gilat Satellite Networks announced that it signed agreements of over $16M for operating the regional transport-networks to support broadband services in Peru. Gilat to provide services over a two-year period. "The outstanding achievement of providing broadband services for the transport networks for the regions of Ayacucho, Apurimac and Huancavelica is in addition to the previously announced Cusco region," said Arieh Rohrstock, Corporate SVP and General Manager Gilat Peru. "This is a huge step in materializing Gilat's strategy to provide services to the transport networks of all six regions that Gilat operates."

07:17 EDT Ocuphire Pharma announces publications featuring Ref-1 protein - Ocuphire Pharma announced the publication of a review article titled "Inhibition of APE1/Ref-1 for Neovascular Eye Disease: From Biology to Therapy" within the Special Issue "Advances in Molecular Activity of Potential Drugs" of the International Journal of Molecular Sciences. APE1/Ref-1 was also featured as a potential therapeutic target for the treatment of age-related macular degeneration in a second published review article titled "Potential Therapeutic Candidates for Age-Related Macular Degeneration" in Cells September 2021 issue. Ocuphire is developing a novel oral Ref-1 inhibitor, APX3330, for the treatment of retinal disease. APX3330 is currently being evaluated in an ongoing, randomized, placebo-controlled, double-masked, multi-center Phase 2 trial in the U.S. for the treatment of diabetic retinopathy with data expected in 2022. The International Journal of Molecular Sciences is an international, peer-reviewed, open access journal providing an advanced forum for biochemistry, molecular and cell biology, molecular biophysics, molecular medicine, and all aspects of molecular research in chemistry. Highlights from the Review Article in International Journal of Molecular Sciences: Details the role of how APE1/Ref-1 protein and its transcription factors impact multiple pro-angiogenic pathways, including angiogenesis, inflammation, oxidative stress, and cell-cycle control in neovascular eye disease; Explains the significance of APE1/Ref-1 activation across several ocular diseases, including age-related macular degeneration, diabetic retinopathy, diabetic macular edema, and retinopathy of prematurity; Provides rationale for developing novel therapeutic agents that target transcription factors of APE1/Ref-1 as a therapeutic approach in neovascular eye disease, highlighting Ocuphire's drug candidate, APX3330, as the first such inhibitor advanced to clinical trials; Describes the critical binding specificity of APX3330 to block the downstream transcription factors of APE1/Ref-1, including NF-kB, HIF1 and STAT3; Describes shortcomings associated with current injectable therapeutics for the treatment of neovascular eye disease, including the anti-VEGF biologics. In addition to the IJMS article described above, a review article titled "Potential Therapeutic Candidates for Age-Related Macular Degeneration" by Dr. Sonali Nashine at the Gavin Herbert Eye Institute at UC Irvine, was recently published in the journal Cells, noting the potential of APX3330 for the treatment of age-related macular degeneration. Because APE1/Ref-1 has been shown to contribute to retinal angiogenesis, the authors conclude that APE1/Ref-1 inhibitors such as APX3330 could inhibit the abnormal blood vessel formation seen in AMD by reducing retinal endothelial cell proliferation, migration, and tube formation.

07:15 EDT Nabors Industries' automated land rig drills first well - Nabors Industries' (NBR) PACE-R801, claimed by Nabor to be the world's first fully automated land drilling rig, has reached total depth on its first well, a horizontal well for ExxonMobil (XOM) in the Permian Basin. The featured automation, robotics and digitalization technologies are available and operational across the Nabors fleet, and those of third parties globally. Insights gained from PACE-R801 have been and will continue to be used to innovate and advance the next generation of Nabors technologies.

07:15 EDT Forma data from novel CBP/p300 study show encouraging safety profile - Forma Therapeutics Holdings announced positive initial results from a Phase 1 trial of its novel CBP/p300 inhibitor, the oral small molecule FT-7051, in men with metastatic castration-resistant prostate cancer, mCRPC. Initial clinical data from the Courage Study, an ongoing first-in-human Phase 1 trial presented at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics, showed an encouraging safety profile of FT-7051, as well as high specificity to the CBP/p300 pathway. "Preliminary data from the Courage Study are promising," said Andrew J. Armstrong, M.D., principal investigator of the Courage Study, and Professor of Medicine, Pharmacology and Cancer Biology, and Director of Research at the Duke Cancer Institute Center for Prostate and Urologic Cancers. "Managing the balance between safety, tolerability and efficacy is a key element of targeting this pathway, and thus far the doses studied are achieving pharmacodynamic target engagement with acceptable tolerability." "There is substantial need for new therapies to treat those with mCRPC as they progress while on existing lines of anti-androgen or chemotherapy," said David N. Cook, Ph.D., senior vice president, Forma Therapeutics' chief scientific officer. "Thanks to the eight patients who participated in the Courage Study to date, we have made progress in understanding the potential of CBP/p300 inhibition in prostate cancer and look forward to continuing our dose escalation study."

07:13 EDT Turning Point Therapeutics provides regulatory update - Turning Point Therapeutics announced the following regulatory updates. Repotrectinib: At the company's anticipated meeting with the U.S. Food and Drug Administration in the first half of 2022 to discuss the topline BICR results from EXP-1 of the TRIDENT-1 study, the company also plans to discuss available BICR data in at least 50 patients from the ROS1-positive TKI-pretreated NSCLC cohorts of the study, with at least six months of follow-up for the majority of responders. Elzovantinib: At a recent End of Phase 1 Meeting with the FDA, the company received guidance on the design of the planned Phase 2 portion of the SHIELD-1 study and feedback on the recommended Phase 2 dose. The meeting focused on the potential next steps for elzovantinib in patients with NSCLC. In the initial feedback, the FDA indicated that the company's Phase 2 design may be acceptable to support a future NDA submission and guided that the adequacy of the data to support accelerated approval would consider the magnitude and duration of responses in a risk-benefit analysis, and will depend on available therapies and the treatment landscape for NSCLC at the time of a potential future NDA submission. The FDA recommended that the company explore an additional intermediate dose level using the QD titration to BID dosing strategy in at least six to 10 patients prior to starting the Phase 2 portion of the study. The company plans to enroll at least six to 10 patients at the dose level of 60 mg QD increased to 60 mg BID after 14 days in the SHIELD-1 Phase 1 to evaluate safety, tolerability and potential anti-tumor activity of elzovantinib. Based on the FDA feedback, the company plans to revise SHIELD-1 into a potentially registrational Phase 1/2 study and initiate the Phase 2 portion of SHIELD-1 in 2022 pending FDA feedback on data from the intermediate dose level. In addition, FDA feedback on the development path for elzovantinib in gastric/gastroesophageal junction cancer is pending.

07:13 EDT Turning Point presents updated preliminary clinical data for repotrectinib - Turning Point Therapeutics announced the presentation of additional preliminary clinical data from ongoing trials for lead drug candidate repotrectinib, and elzovantinib, a novel MET/SRC/CSF1R inhibitor. These data are being presented at the Virtual International Conference on Molecular Targets and Cancer Therapeutics hosted by the American Association for Cancer Research, the National Cancer Institute, and the European Organisation for Research and Treatment of Cancer being held October 7-10. Repotrectinib Updated Phase 2 Data from TRIDENT-1 Study from ROS1-Positive TKI-Pretreated Advanced Non-Small Cell Lung Cancer Cohorts: Pooled Phase 1 and Phase 2 Preliminary Efficacy Analysis: In the ROS1-positive advanced NSCLC population pretreated with one prior TKI and prior platinum-based chemotherapy, the confirmed Objective Response Rate, cORR, was 39%. Duration of response ranged from 1.8+ to 11.1 months. In the ROS1-positive advanced NSCLC population pretreated with two prior TKIs without prior chemotherapy, the cORR was 30%. Duration of response ranged from 1.9+ to 12.9+ months. In the ROS1-positive advanced NSCLC population pretreated with one prior TKI without prior chemotherapy, the cORR was 38%. As of the cutoff date, three patients had unconfirmed partial responses, all of which have been confirmed since the cutoff date and are included in the cORR. Across EXP-2, EXP-3 and EXP-4, 18 patients had a ROS1 resistance mutation detected, 15 of which had G2032R solvent front mutations. The cORR was 50% in 18 patients with any resistance mutation and 53% in patients with a G2032R SFM which included two complete responses. Preliminary Safety Analysis: Repotrectinib was generally well tolerated. The most frequently reported treatment-emergent adverse event was low-grade dizziness of which 76% of reported cases were grade 1. Eleven patients reported ataxia in the absence of dizziness. No events of dizziness or ataxia led to treatment discontinuation. Dose modifications due to TEAEs included 27% of patients who had dose reduction and 11% who had drug discontinuation.

07:10 EDT Cerevel Therapeutics to host R&D event on CVL-871, CVL-231 - Cerevel Therapeutics will host a virtual R&D event from 10:00 to 11:30 a.m. ET. Presented in a live webcast format, Cerevel will discuss CVL-871, a dopamine D1/D5 receptor partial agonist in development for the treatment of dementia-related apathy, and provide an update on CVL-231, a muscarinic M4 positive allosteric modulator in development for the treatment of schizophrenia. This R&D event is one of a series of virtual webcasts dedicated to providing in-depth discussions on key portfolio programs. CVL-871 is currently being studied in a Phase 2a exploratory trial to evaluate the compound as a potential treatment for dementia-related apathy. Apathy is among the most common neuropsychiatric co-morbidities associated with dementia, is one of the strongest predictors of disease progression, and is associated with higher mortality risk and early institutionalization. During today's discussion, key members of Cerevel's scientific and clinical teams will be joined by Dr. Krista Lanctot, Professor of Psychiatry and Pharmacology/Toxicology at the University of Toronto, a leading expert in the neuropsychiatric manifestations of dementia, including apathy. Cerevel received Fast Track designation for the development of CVL-871 in this indication from the U.S. Food and Drug Administration earlier this year. Data from the ongoing Phase 2a trial are expected in the second half of 2022. CVL-231 is in development as a potential treatment for schizophrenia. In June, Cerevel announced positive topline results from its Phase 1b trial of CVL-231 and plans to initiate a comprehensive Phase 2 development program. Cerevel also intends to explore CVL-231 for other populations, including dementia-related psychosis.

07:09 EDT Green Thumb Industries announces expansion of Rise Mundelein in Illinois - Green Thumb Industries announced it will host a grand reopening for its newly expanded retail store, Rise Mundelein, on October 16. A patient and guest appreciation event will take place on Saturday, October 16 from 8 a.m. to 11 a.m. and will include a ribbon cutting ceremony at 8:30 a.m. Mundelein Mayor Steve Lentz will be in attendance.

07:08 EDT Gatos Silver reports record plant throughput, mined tonnage from CLG mine in Q3 - Gatos Silver reported record plant throughput and mined tonnage from the 70%-owned Cerro Los Gatos, or CLG, mine during Q3. Gatos Silver mined a record 242,899 ore tons from CLG in Q3, exceeding the Q2 record tonnage by 1.2%. The plant also achieved record processing throughput in Q3 totaling 234,054 tons, exceeding Q2 performance by 1.5%. Year-to-date 2021, 692,778 ore tons were mined from CLG and the plant processed 668,189 tons, a 53% and 42% increase, respectively, over the same period in 2020, partly due to a 45-day pandemic-related suspension. Silver production in Q3 was approximately 20% lower than in Q2, due to lower silver grades in mined ore which occurred as a result of mine sequencing. Lead and zinc production in Q3 was also slightly lower than in Q2, due to 5% lower lead and zinc grades in the mined ore. Q3 recoveries for silver, lead and zinc continued to exceed design and were consistent with Q2. The operation is well on track to achieve record annual 2021 production for all payable metals.

07:07 EDT Renalytix launching KidneyIntelX in Veterans Health Administration hospitals - Renalytix announced the expansion of its commercial strategy to address early-stage kidney disease in the Veterans Health Administration patient population with the appointment of Jed Fulk to the position of Vice President Sales, Government Accounts. Mr. Fulk is developing and leading a team expected to grow to 42 regional sales managers and account executives during calendar year 2022 to support KidneyIntelX rollout to the VA Health System. KidneyIntelX will be deployed to help VA primary care physicians to identify diabetic kidney disease patients at high and low risk for rapid progression and kidney failure.

07:05 EDT Lantronix opens Lantronix Design Center in Ilmenau, Germany - Lantronix announced the opening of its new Lantronix Design Center in Ilmenau, Germany, in support of its EMEA customers. The grand opening event is scheduled for Oct. 15, 2021. The new Lantronix Design Center in Germany will be home to an engineering group encompassing design engineering, system architecture, technical support, quality assurance and test services. The team of engineers and support staff will work with Lantronix's EMEA customers and partners as well as local and federal governments to assist in the design of innovative new IoT solutions. From fixed-cost turnkey product development to augmenting design teams on complex projects, Lantronix's Design Center team helps its customers meet their technical goals and quickly get products to prototype and market.

07:05 EDT Tilray says on track for $80M in cost-savings from Aphria combination - Tilray announced cost-saving synergies of $55M were achieved on a run-rate basis to date, with actual cash-savings close to $20M. The company is on-track for at least $80M in cost-savings from Aphria and Tilray business combination synergies.

07:04 EDT Westlake Chemical and Nexii partner for sustainable building - Westlake Chemical subsidiary Westlake Innovations and Nexii Building Solutions have formed an alliance to support the construction of buildings with a reduced environmental footprint. Also, Westlake will be the preferred supplier of certain building materials it makes for Nexii residential construction, including siding, stone, roof tiles, trim and molding, pipe and fittings. Nexii is a green construction technology company that designs and manufactures buildings and building products that are sustainable, cost-efficient and resilient in the face of climate change. Headquartered in Vancouver, British Columbia, Nexii has a proprietary material, Nexiite, that has comparable properties to concrete but contains no Portland cement or lime, reducing carbon emissions.

07:03 EDT Big Ten Network selects Sportradar to refresh B1G+ - Sportradar and the Big Ten Network have partnered to relaunch B1G+, a direct-to-consumer subscription service for non-televised events powered by the Big Ten Network. The revitalized B1G+ includes approximately 1,500 live streams of Big Ten Olympic sports, as well as video-on-demand of basketball and football games that previously aired on linear channels.

07:02 EDT Colliers International to acquire Antirion, terms not disclosed - Colliers announced it has entered into an agreement to acquire a controlling interest in Antirion SGR S.p.A., one of the largest real estate investment management firms in Italy with assets throughout Western Europe. Ofer Arbib, founder and CEO and his team will continue to lead the organization and will retain a significant equity interest in the firm going forward under Colliers' unique partnership model. The firm will be rebranded as Colliers Global Investors shortly after closing. This investment further expands Colliers Global Investors' growing platform in Europe and leverages its benefits for existing and new investors. The transaction is subject to customary closing conditions and is expected to close in the first quarter of 2022. Details of the transaction were not disclosed. Founded in 2009 in Milan, Antirion has become one of the most prominent and highly respected real estate investment management firms based in Italy. With more than EUR3.8 billion of assets under management, Antirion has consistently delivered strong returns for investors over the long-term across ten funds primarily through investments in office, hospitality, retail, and residential asset classes. The firm employs 35 professionals that cover the region from offices in Milan and Rome.

07:00 EDT Blackstone to acquire VFS Global - Blackstone, EQT and the Kuoni and Hugentobler Foundation announce that funds managed by Blackstone Capital Partners have signed a definitive agreement with EQT VII fund and KHF to acquire a majority stake in VFS Global. EQT Private Equity will remain indirectly invested in the company with a minority position alongside Blackstone. Blackstone, as majority shareholder, and KHF, as minority shareholder, will be co-investors in the company following the closing of the transaction. "VFS Global is the global market leader in visa outsourcing services, headquartered in Zurich, Switzerland and Dubai, UAE. Founded by its current CEO, Zubin Karkaria in 2001, the Company pioneered the professionalization of the visa market. It is now the largest provider of visa outsourcing and technology services to governments and diplomatic missions worldwide. VFS Global services more than 60 client governments through ~3,500 visa application centres in over 140 countries across five continents," Blackstone stated.

06:59 EDT Geo Group 'pleased' with appeals court ruling vs. AB32 law - The GEO Group commented on the favorable ruling by the U.S. Court of Appeals for the Ninth Circuit in relation to lawsuits filed by GEO and the United States for declaratory and injunctive relief challenging California's enacted law, Assembly Bill 32, which would bar the federal government from engaging government contractors to provide services at federal immigration processing centers. On October 5, 2021, the Ninth Circuit Court of Appeals reversed a prior U.S. District Court decision dismissing the requests by GEO and the United States for declaratory and injunctive relief and ruled that AB32 conflicts with federal law in violation of the Supremacy Clause of the U.S. Constitution and discriminates against the federal government in violation of the intergovernmental immunity doctrine. The case is remanded to the U.S. District Court for further proceedings, consistent with the Ninth Circuit Court of Appeals ruling. Commenting on the ruling, GEO's Executive Chairman, George Zoley, said, "We are pleased with this ruling and anticipate it will allow the continuation of our California civil detention support services contracts for the U.S. Department of Homeland Security, which are effective through December 19, 2034."

06:56 EDT Brickell Biotech reports 'positive' results from Phase 3 Cardigan I, II studies - Brickell Biotech announced positive topline results from the Phase 3 pivotal Cardigan I and Cardigan II studies, which evaluated sofpironium bromide gel, 15% as a once daily topical formulation in patients with primary axillary hyperhidrosis. "We are excited to report the positive topline results from our pivotal Phase 3 clinical studies. These data are highly encouraging and further reinforce our belief that sofpironium bromide gel, 15% has the potential to become a best-in-class treatment option for the millions of patients suffering from primary axillary hyperhidrosis," said Robert Brown, CEO of Brickell. "The results from the Cardigan I and Cardigan II studies, along with all previously completed clinical studies, will form the basis for a U.S. NDA for sofpironium bromide gel, 15%, which we expect to submit to the FDA in mid-2022. We are tremendously appreciative of the collaborative and diligent efforts of our patients, study investigators, partners and employees who participated in or contributed to these studies. This was a huge team effort, and we are thankful to all of those involved in making our Phase 3 program a success." "These data demonstrate that once-daily topical sofpironium bromide gel, 15% achieved early, sustained and significant improvements in primary axillary hyperhidrosis signs and symptoms consistent across all efficacy measures and was generally well-tolerated over six weeks of treatment," commented Stacy Smith, MD, a practicing dermatologist. "I feel privileged to have served as a principal investigator in the U.S. pivotal Phase 3 program. There is a real need for new and improved hyperhidrosis treatment options, and the results from these pivotal Phase 3 studies further support the potential for sofpironium bromide gel, 15% to become a first-line therapy of choice for patients with primary axillary hyperhidrosis."

06:52 EDT Rocket Lab selected to launch NASA's Advanced Composite Solar Sail System - Last night, Rocket Lab "announced that it has been selected to launch NASA's Advanced Composite Solar Sail System, or ACS3, on the Electron launch vehicle. ACS3 will launch as part of a rideshare mission, scheduled for lift-off from Rocket Lab Launch Complex 1 in mid-2022. The ability of the Electron launch vehicle's Kick Stage to deploy individual satellites to unique orbits, even when flying as part of a rideshare, was a key factor in Rocket Lab being selected as the launch provider. ACS3 requires a higher altitude than the other rideshare payloads launching on the same mission, so after deploying the first payloads, the Kick Stage will perform another burn with its 3D printed Curie engine to raise the orbit and deploy ACS3. Rocket Lab's Kick Stage has demonstrated orbit raises across 18 missions to date, and also successfully conducted inclination changes and orbit lowering, providing customers with proven, flexible, and precise in-space transportation." Shares of Rocket Lab are up 8.4% in early pre-market trading at $15.17.

06:49 EDT Becton Dickinson increases manufacturing capacity, domestic supply in Nebraska - Becton Dickinson announced it has strengthened the U.S. government's access to safety injection devices through increased manufacturing capacity and domestic supply. The new syringe and needle manufacturing lines, which were completed on an accelerated timeline, represent the public-private partnership between BD and Department of Health and Human Services' Assistant Secretary for Preparedness and Response, or ASPR. In July 2020, ASPR's Biomedical Advanced Research and Development Authority, or BARDA, invested approximately $42M into a $70M capital project to further expand BD's operations and manufacturing lines in Holdrege, Nebraska. The expansion builds on the company's commitment and legacy in supporting U.S. vaccination efforts through the domestic manufacturing of needles and syringes. The new lines increase capacity of BD's existing needle and syringe supply capabilities domestically. To date, the company has provided several hundred million injection devices to the federal campaign. This marks a manufacturing milestone as the United States heads into flu vaccination season and the need for these devices continues. Increasing supply capacity from the company's Holdrege facility builds on a 70-year manufacturing legacy in the state. BD operates three other manufacturing facilities in Nebraska: Broken Bow and two facilities in Columbus.

06:43 EDT DarioHealth announces agreement for MSK health solutions with U.S. company - DarioHealth announced an agreement with a company based in the United States to provide its integrated digital health management solution for diabetes, hypertension, and musculoskeletal, or MSK, health. The contract is expected to launch in the first quarter of 2022. The company selected Dario to provide a personalized approach to chronic condition management.

06:40 EDT Sierra Metals initiates annual base dividend of 3c per share - Sierra Metals has authorized the payment of an annual dividend to consist of a base dividend of $5M or 3c per share plus an additional amount based on available cash flows generated each year after accounting for planned capital spending, distributions to non-controlling interests, greenfield exploration and mandatory debt service. The initial dividend is expected to be declared in November and paid to shareholders in December.

06:39 EDT Ault Global Holdings provides update on installation of S19j Pro Antminers - Ault Global Holdings announced that its wholly owned subsidiary, BitNile, is actively installing the first 1,000 S19j Pro Antminers recently received at the company's Michigan data center. On September 15, the company announced that it expects to receive an additional 300 Antminers per month between October 2021 and July 2022, bringing the total new Antminers to be deployed to 4,000. BitNile expects the first 1,000 miners will be fully operational by the end of October 2021 and will generate cryptocurrency mining revenue of approximately $1M per month, based on a Bitcoin trading price of approximately $45,000. BitNile further expects to grow cryptocurrency mining revenue to approximately $4M per month after installation of all 4,000 Antminers, which is expected to be completed by August 2022. While the company believes that the future operations of the Data Center and its cryptocurrency mining operations will be successful, the company cannot assure that it will receive all the Antminers, that the price of Bitcoin will remain high enough to generate profits or that its expectations will materialize in a timely manner, if at all.

06:35 EDT Amgen, Neumora enter collaboration to advance neuroscience discovery - Amgen and Neumora Therapeutics announced a strategic collaboration to advance neuroscience discovery, development and commercialization. The companies will collaborate on programs by applying Neumora's proprietary precision neuroscience platform to insights generated by Amgen's deCODE genetics and human data research capabilities. In addition, Neumora has received a $100M equity investment from Amgen and acquired exclusive global rights to develop and commercialize Amgen programs targeting casein kinase 1 delta and glucocerebrosidase for neurodegenerative diseases.

06:34 EDT Comstock Resources sells Bakken shale assets for $154M to Northern Oil and Gas - Comstock Resources (CRK) has entered into an asset purchase agreement with Northern Oil and Gas (NOG) to sell its assets in the Bakken shale for $154M in cash, subject to adjustment and customary closing conditions. The properties being sold include non-operated interests in over 400 producing wells - 65.9 net - with recent production of greater than 4,500 net barrels of oil equivalent per day, approximately 65% oil. The sale is expected to close in Q4 and will have an effective date of October 1. Comstock expects to recognize a pre-tax loss of $130M-$140M on the divestiture. Comstock plans to re-invest the proceeds from the property sale into its Haynesville shale development program, including the acceleration of completing 13 - 9.4 net - drilled and uncompleted wells which were originally budgeted to be completed in 2022. Comstock may also use a portion of the proceeds to acquire additional leasehold and to fund additional drilling activity in 2022.

06:33 EDT inTEST acquires assets of Z-Sciences Corp., terms not disclosed - inTEST announced it has acquired substantially all of the assets of Z-Sciences Corp., a developer of ultra-cold storage solutions for the medical cold chain market. The terms of the Z-Sciences acquisition were not disclosed.

06:25 EDT Relief announces filing of lawsuit against NeuroRx and CEO Jonathan Javitt - Relief Therapeutics (RLFTF) announced that it has filed a lawsuit against NeuroRx (NRXP) and its CEO, Dr. Jonathan Javitt, for multiple breaches of the Collaboration Agreement between Relief and NeuroRx relating to the development and commercialization of RLF-100. The complaint was filed in the Supreme Court of the State of New York in Manhattan. The complaint alleges that the defendants are in breach of numerous provisions of the Collaboration Agreement, including without limitation by "failing to provide Relief with the full data set from NeuroRx's recently completed phase 2b/3 clinical trial evaluating IV RLF-100 for the treatment of acute respiratory failure due to COVID-19, which data and information are required to be provided to Relief by NeuroRx under the Collaboration Agreement and which data and information are required for Relief to seek approval to commercialize the product in Europe." The Complaint, among other remedies, seeks damages, an order compelling defendants to comply with multiple provisions of the Collaboration Agreement, and a declaration directing NeuroRx to deliver the entire data set from the Phase 2b/3 clinical trial of intravenously-administering aviptadil to Relief, Relief said in a statement.

06:09 EDT CytoDyn announces study evaluating leronlimab with immune checkpoint blockade - CytoDyn announced a study for treating triple-negative breast cancer with leronlimab in a humanized TNBC xenograft model. This investigator-initiated study is being led by Jangsoon Lee, Ph.D., assistant professor of Breast Medical Oncology Research at The University of Texas MD Anderson Cancer Center. The study is intended to determine the potential synergistic therapeutic efficacy of leronlimab in combination with immune checkpoint blockade to attempt to raise the standard of care for breast cancer patients.

06:08 EDT High Tide acquires Blessed CBD in the U.K. - High Tide entered into a definitive agreement pursuant to which High Tide will acquire 80% of Enigmaa, operating as Blessed CBD, for GBP9.06M, and will have a three-year option to acquire the remaining 20% of Blessed at any time. Founded in 2019 with its headquarters in Scotland, Blessed is a brand for hemp-derived CBD products across the U.K., including CBD oils, creams, gummies, and capsules. In 2020 Blessed had almost 5 million site visits and an average order value of approximately GBP 75. Blessed's founder and CEO, Vithurs Thiru, will join the High Tide team as Senior Manager of Search of the company. The consideration for the 80% acquired will be comprised of GBP4.9M in common shares of High Tide and GBP4.2M in cash. The cash portion of the transaction will be funded entirely with cash on hand. Blessed's founder has agreed to grant High Tide an option to acquire all the remaining shares in Blessed not held by High Tide at an enterprise value equal to the trailing 12 months of revenue at that time multiplied by 2.2. The Call Option will be exercisable at any time for a period of 3 years following the closing.

06:05 EDT CytoDyn announces legal actions against Amarex Clinical Research - CytoDyn announced the filing of a complaint for declaratory and injunctive relief and motion for a preliminary injunction against NSF International, Inc. and its subsidiary Amarex Clinical Research, the company's former Contract Research Organization. Over the past eight years, Amarex provided clinical trial management services to the company and managed numerous clinical trials. The company's complaint alleges that Amarex failed to perform its obligations under the master services agreement and work orders that governed the relationship between the parties. As a result, the company suffered substantial damages. The company's lawsuit filed in the U.S. District Court for the District of Maryland seeks a declaration that Amarex breached its contracts with CytoDyn, as well as an injunction requiring Amarex to provide CytoDyn access to databases of clinical trial data that Amarex has been wrongfully withholding. The company simultaneously filed a demand for arbitration with the American Arbitration Association. The arbitration demand alleges that Amarex failed to perform services to an acceptable professional standard and failed to perform certain services required by the parties' agreements. Further, the demand alleges that Amarex billed the company for services it did not perform. The company contends that, due to Amarex's failures, it has suffered avoidable delays in obtaining regulatory approval of leronlimab and has been paid for services not performed. Furthermore, as part of reinstating the "rolling review" status for the company's BLA resubmission, the FDA has requested potential submission dates for each component of the BLA. The company communicated to the agency that it will submit its CMC and non-clinical sections in November. The company also reported to the FDA the clinical section could be delayed to the first quarter of 2022, however, certain portions may be submitted earlier during the review, if acceptable to the FDA.

06:03 EDT MasterCard, Citi expand partnership to support local residents, small businesses - Mastercard (MA) and Citi (C) announced a new partnership to support local residents and small businesses through greater public-private sector collaboration. Through City Possible, Mastercard's partnership and co-creation framework for cities, the two global leaders will bring their collective resources, expertise, and integrated urban development frameworks to the City Possible network. The partnership will initially grant City Possible network members access to "Citi Start Saving" and "City Builder by Citi" through the Mastercard City Insights Digital Marketplace. The Citi Start Saving program allows U.S. municipal and nonprofit organizations to expand access to financial services and advance economic progress in underserved and low-income communities. City Builder by Citi is a free, data-driven platform that aggregates information about community investment opportunities and includes information on 16,000+ U.S. cities, 73,000 census tracts, 485 community development projects, and 180 funds and community development entities. The new tools will provide City Possible members the ability to assess the impact of a climate or economic event to support policy and program development. The partnership will also explore ways to help city leaders develop more efficient procurement processes as well as identify avenues to support an inclusive recovery through joint disbursement solutions.

06:01 EDT Lululemon to offer MIRROR in Canada - Lululemon announced that MIRROR, its popular nearly invisible interactive home gym, will be offered in nearly 40 lululemon stores across Canada and available for purchase in-store and online beginning on November 22. Guests in Canada will now have direct access to engage with MIRROR's digital community and experience the platform's best-in-class content for all levels. This expansion in Canada will increase MIRROR's in-store presence to almost 200 lululemon locations in North America and help propel lululemon's vision to strengthen its community connection through the platform.

05:33 EDT Maravai Lifesciences issued new CleanCap technology patent from EPO - Maravai LifeSciences announced that the European Patent Office, or EPO, has issued a new patent to the company's TriLink BioTechnologies subsidiary. The patent relates to TriLink's CleanCap technology for the co-transcriptional capping of messenger RNAs, or mRNAs. Capping is an important step in the production of synthetic mRNA, which is used to develop nucleic acid vaccines and therapeutics that deliver instructions to human cells to produce proteins that may prevent or correct disease. The technology described by European Patent No. 3352584 facilitates the production of mRNAs and provides a significant improvement over legacy co-transcriptional capping methods.

05:16 EDT Moderna invests $500M to build mRNA facility in Africa - Moderna announced it will build a mRNA facility in Africa with the goal of producing up to 500M doses of vaccines each year at the 50 microgram dose level. The company anticipates investing up to $500M in this new facility which is expected to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site. The company expects to begin a process for country and site selection soon. Moderna and its partners have ramped up capacity worldwide and have supplied more than 500M doses of Moderna's COVID-19 vaccine to date. As recently announced, there are several efforts to continue increasing capacity at a significant pace. This announcement is a new investment aimed at adding a manufacturing site in Africa to Moderna's expanding global network.

05:11 EDT Nokia selected by Lightstorm to deploy digital operations software - Nokia announced that it has been selected by Lightstorm, India's first carrier-neutral network infrastructure platform, to deploy its digital operations software. Nokia will automate Lightstorm's service fulfilment and service assurance processes, enabling the company to create new revenue streams by offering network-as-a-service, or NaaS, solutions to their enterprise customers. The deployment is underway across India and will be implemented on Amazon Web Services (AMZN), or AWS.